APRIL 2006

WEEK ENDING APRIL 1

PRODUCT
a) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
b) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
c) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
d) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
e) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
f) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
g) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
h) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
CODE
a) Lot # W05-0884;
b) Lot # W05-0909 and W05-0686;
c) Lot # W05-0511;
d) Lot # W05-0514 and W05-0969;
e) Lot # W05-0764;
f) Lot # W05-0512 and W05-0912;
g) Lot # 05-0513 and W05-883;
h) Lot # W05-0765
RECALLING FIRM/MANUFACTURER Endologix, Inc., Irvine, CA
REASON The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
VOLUME OF PRODUCT IN COMMERCE 145 units
DISTRIBUTION AZ, DE, KS, PA, and TN

PRODUCT Baxter Auto Syringe AS50 Infusion Pump, product code 1 M8550
CODE Serial numbers 15060001AB, 15060002AB, 15060004AB/15060013AB, 15060015AB/15060021AB, 15060023AB/15060073AB, 15060075AB, 15060077AB/15060116AB, 15060116AB, 15060118AB/15060126AB, 15060128AB/15060130AB, 15060132AB/15060172AB, 15060174AB/15060209AB, 15070003AB/15070006AB, 15070008AB/15070018AB, 15070021AB, 15070023AB, 15070026AB/15070034AB, 15070037AB15070041AB, 15070044AB/15070047AB, 15070049AB/15070052AB, 15070056AB/15070059AB, 15070066AB, 15070069AB, 15070071AB, 15070072AB, 15070076AB, 15070077AB, 15070079AB, 15070081AB, 15070082AB, 15070084AB, 15070086AB, 15070087AB, 15070092AB, 15070094AB/15070096AB, 15070099AB, 15070101AB, 15070109AB, 15070111AB/15070115AB, 15070117AB, 15070119AB, 15070121AB, 15070122AB, 15070124AB, 15070126AB/15070128AB, 15070130AB/15070132AB, 15070138AB/15070140AB, 15070144AB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL.
Manufacturer: Baxter Healthcare Corp., Singapore
REASON A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
VOLUME OF PRODUCT IN COMMERCE 282 pumps
DISTRIBUTION Nationwide

PRODUCT
a) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number CC1301 (Reorder No. 21-0334-01)Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites
b) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 1 needless injection site,
c) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume,
20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber, CODE
a) Lot number: MAR04T22;
b) Lot number: FEB04T15;
c) Lot number: FEB04T06
RECALLING FIRM/MANUFACTURER Smiths Medical MD, Inc., Saint Paul, MN
REASON Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
VOLUME OF PRODUCT IN COMMERCE 13 boxes for a total of 450 individual Administration Sets
DISTRIBUTION SC, Australia, Canada and PR

PRODUCT
a) Groshong nXt ClearVue 4 Fr Single-Lumen PICC, Product code 7617405,
b) Groshong nXt ClearVue 4 Fr. Single-Lumen PICC, Product Code 7617408, 
c) Groshong nXt 5 Fr. Dual-Lumen Reverse Taper PICC, Product Code 7827508,
d) Groshong nXt 5 Fr. Dual-Lumen Reverse Taper PICC, Product Code 7927508
CODE
a) Lot # REPI0344;
b) Lot # REPI0738;
c) Lot # REPI0650;
d) Lot # REPI10649, REPI0911
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Inc, Salt Lake City, UT
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico, 
REASON Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
VOLUME OF PRODUCT IN COMMERCE 1,848 units
DISTRIBUTION Nationwide

Ossur Announces  Recall of Certain Models of the Total Knee®

Ossur hf. (ICEX: OSSR) announced a recall of the 1100, 1900, 2000 and 2100 models of its Total Knee® prosthetic device. The company's initiation of the recall, effective immediately, is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee.

The serial numbers of the affected knees, which were ordered from June 7th, 2005 to present, have been identified. The O & P facilities who have provided a Total Knee that contains the affected serial number will receive a letter and a phone call with the proper replacement procedure in the next few days.

In addition, Ossur has temporarily suspended sales and shipments of Total Knees until further notice. To expedite this process in the consideration of both its customers and patients, the implementation of a replacement program will be effective immediately.

  You may access the company website at http://www.ossur.com/ for this information.

If you have additional questions, you may contact Ossur at the following numbers:
United States & Canada: 800 233 6263
Europe: +31 499 462 840
Scandinavia: +46 1818 2200
Asia-Pacific: +61 2 9630 9206
Other countries: +354 515 1342

WEEK ENDING APRIL 8

Disetronic Medical Systems, Inc. Announces a Nationwide Recall Of All ACCU-CHEK™ Ultraflex Infusion Sets

  Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind.is recalling all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

This recall applies to all ACCU-CHEK™ Ultraflex infusion sets. Patients using any standard luer-lock insulin pump may also be using these ACCU-CHEK™ Ultraflex infusion sets. Disetronic is advising customers to check their infusion sets at the luer lock-tubing connection at least every 3 hours and before bedtime.

Under this recall, customers have the option of continuing to use their ACCU-CHEK™ Ultraflex infusion set, and receiving replacement ACCU-CHEK™ Ultraflex infusion sets for any products exhibiting full or partial separation of the luer lock-tubing connection. Customers deciding to continue using the ACCU-CHEK™ Ultraflex or a replacement ACCU-CHEK™ Ultraflex infusion set, must check their infusion set at the luer lock-tubing connection during use at least every 3 hours and before bedtime.   The replacement ACCU-CHEK Ultraflex infusion sets may still experience this full or partial separation of the luer lock-tubing connection.

Customers also have the option of replacing their ACCU-CHEK™ Ultraflex infusion sets with ACCU-CHEK™ Tender, or ACCU-CHEK™ Rapid-D infusion sets.

Customers that have fully or partially separated tubing sets, or wish to discontinue use of their ACCU-CHEK Ultraflex Infusion Set may call Disetronic Medical Systems Pump Support at 1-800-688-4578 for replacement. If you do experience product problems, you should contact Disetronic, for a pre-paid mailer in order to send the affected infusion set back to Disetronic for analysis.

If you are a physician or a patient who has experienced a problem with any ACCU-CHEK™ Infusion Sets, please notify Disetronic at 1-800-688-4578.

Infusion set customers who purchased the ACCU-CHEK Ultraflex Infusion sets should always follow labeling instructions for proper use. In addition, healthcare officials suggest that diabetes patients who are on insulin pump therapy should check their blood glucose levels 1-3 hours after changing the infusion set systems, and continue to check throughout the day as instructed by their healthcare provider.

In the course of normal daily use, infusion sets can be subjected to a variety of stresses, including bending at the luer lock-tubing connection, which can lead to full or partial separation at the luer lock-tubing connection. Therefore, the potential for separation of the luer lock-tubing connection still exists with the replacement ACCU-CHEK™ Ultraflex infusion set. Information and illustrations that depict the luer lock-tubing connection can be found on Disetronic's website at http://www.disetronic-usa.com/.

ACCU-CHEK™ Ultraflex Infusion Sets are available by prescription only for diabetes patients who use insulin pump therapy. The firm is notifying by direct mail affected customers, healthcare providers and its distributors of this action.

PRODUCT Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device,
CODE Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA
Manufacturer: Cmt Medical Technologies Ltd, Haifa, Israel,
REASON When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.
VOLUME OF PRODUCT IN COMMERCE 5 devices
DISTRIBUTION Nationwide

PRODUCT
a) Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0", mL Vol., with 2 Luer Activated Valves and a male Luer Lock adapter;
b) Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; 
c) Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4", 0.4 mL Vol., with male Luer Slip T-Connector,
d) Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194, An Rx sterile, nonpyrogenic fluid pathway, 7.0", 0.3 mL Vol., with male Luer Lock adapter
e) Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapter;
f) Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0", 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock adapter with retractable collar and 1 Interlink Y-injection site. 
g) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36", 0.38mL Vol, with male Luer Lock adapter, 
h) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60", 0.5mL Vol, with male Luer Lock adapter, 
i) Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; 
j) Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.5 mL Vol., with injection site and male Luer Lock adapter with Retractable Collar.
k) Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61", 0.9 mL Vol., with male Luer Lock adapter, 
l) Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic fluid pathway, 72", 1.7 mL Vol., with Luer Lock adapters, 
m) Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0", 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter, n) Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.6 mL Vol., with injection site and male Luer Lock adapter, 

o) Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0", 0.4 mL Vol., with male Luer Lock adapter,
p) Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Lock adapter, 
q) Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Extended Life Filter and male Luer Lock adapter,
r) Baxter Interlink System Minivolume Extension Set, product code 1C8483; An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter,
s) Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22", 0.9 mL Vol, with injection site and Stationary Swivel Lock T-Connector, 
t) Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7", 0.3 mL Vol, with Male Luer Slip T-Connector, 
u) Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8", 0.22 mL Vol, with male Luer Lock adapter, 
v) Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension set: 19", 3.2 mL Vol., with injection site and male Luer Lock adapter, manifold extension set: 46", 6.2 mL Vol, male luer adapter, and minivolume extension set: 10", 0.7 mL Vol, injection site and stationary swivel lock T-connector, 
w) Baxter Interlink System 3-Lead Extension Set, product code 1C8442; An Rx sterile, nonpyrogenic fluid pathway, 6", 1.6 mL Vol., with 2 Interlink Injection Sites and a Male Luer Lock adapter;, 
x) Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter, 

y) Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0", 0.33 mL Vol., with male Luer Lock adapter, 
z) Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway, 7.0", 0.33 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter, 
aa) Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0", 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter, 
bb) Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Lock adapter, 
cc) Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway; solution set: 74", 60 drops/mL, with injection site and male Luer Lock adapter, manifold extension set: 29", 4 mL Vol, male luer adapter, and minivolume extension set: 7", 0.4 mL Vol with retractable T-connector. 
dd) Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic fluid pathway; solution set: 58", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection sites and male Luer Lock adapter, stopcock extension set: 43", 6.5 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6", 0.4 mL Vol with male
luer slip T-connector, 
ee) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set and Minivolume Extension Set, product code 3C0128; An Rx sterile, nonpyrogenic fluid pathway; solution set: 105", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection
sites and male Luer Lock adapter, stopcock extension set: 34", 5.2 mL Vol with injection site, minivolume tubing and male luer adapter, and minivolume extension set: 3", 0.1 mL Vol with male luer lock adapter, 
ff) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution set: 84", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 21",
3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6", 0.5 mL Vol with microvolume tubing and retractable T-connector, 

gg) Baxter Minivolume Extension Set, product code JC9944; An Rx sterile, nonpyrogenic fluid pathway, 8", 0.4 mL Vol., with Luer Activated Valve, Made in Canada, 
CODE
a) Lots UR254482, UR254763, UR255752;
b) Lots UR254839, UR255547;
c) Lot UR254987;
d) Lots UR255257, UR265512, UR255257;
e) Lots UR253385, UR255331, UR255505, UR261248, UR272211;
f) LotsUR254540, UR254847, UR260364;
g) Lots UR254961, UR255216;
h) Lots UR254581, UR255059, UR258806, UR258921;
i) Lots UR258939, UR258996, UR259150, UR259200;
j) Lot UR255125;
k) Lot UR244491;
l) Lots UR254607, UR255240;
m) Lots GR225490, GR227587, GR230052;
n) Lots GR225508, GR228395, GR230912, GR232058;
o) Lots GR226324, GR226803, GR228429, GR229781, GR230649, GR230854;
p) Lots GR225102, GR225359;
q) Lots GR227140, GR230664, GR231852, GR224659;
r) Lots GR227579, GR224238;
s) Lot GR228668;
t) Lots GR226811, GR228064;
u) Lots GD819433, GD819938, GR224675;
v) Lots GR226944, GR231183, GR224683;
w) Lots GR226340, GR228460;
x) Lots GR227173, GR228114, GR230060, GR224667;
y) Lot GD814186;
z) Lot GR225904;
aa) Lots GR228619, GR228874, GR228882, GR229179, GR231746;
bb) Lots GR229351, GR229500, GR229906, GR231050, GR231068, GR232371;
cc) LotsGR229013, GR229799;
dd) Lots GR228981, GR229591, GR232033;
ee) Lots GR229609, GR230805;
ff) Lot GR230631;
gg) Lots ST05A165, ST05G091
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corporation, Round Lake, IL, 
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR,
REASON The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
VOLUME OF PRODUCT IN COMMERCE 556,182 sets
DISTRIBUTION Nationwide and Internationally

PRODUCT Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse Co¬Oximeter, 
CODE Serial Numbers: 4793 5108 5405 5792 6096 6261 6421 6576 4794 5109 5506 5797 6118 6263 6436 6578 4818 5115 5513 5800 6136 6265 6441 6596 4821 5123 5530 5811 6140 6266 6444 6604 4833 5139 5538 5816 6146 6268 6451 6608 4836 5169 5571 5828 6148 6274 6463 6628 4852 5176 5579 5838 6149 6277 6473 6638 4854 5182 5588 5839 6153 6283 6478 6645 4860 5186 5589 5841 6158 6287 6481 6664 4866 5187 5592 5845 6159 6288 6482 6666 4870 5191 5597 5848 6164 6302 6483 6668 4875 5194 5599 5852 6166 6304 6484 6671 4880 5196 5601 5856 6168 6309 6487 6673 4881 5197 5608 5868 6169 6310 6488 6678 4886 5199 5610 5870 6172 6311 6489 6680 4887 5201 5613 5872 6173 6313 6492 6683 4895 5219 5616 5877 6174 6318 6493 6686 4898 5220 5619 5884 6178 6320 6495 6690 4912 5221 5620 5934 6179 6321 6498 6696 4914 5224 5621 5939 6180 6324 6503 6697 4915 5226 5625 5949 6183 6325 6509 6743 4933 5233 5635 5960 6189 6326 6511 4934 5235 5649 5961 6196 6329 6514 4939 5236 5652 5966 6198 6333 6515 4968 5237 5656 5971 6199 6337 6517 4992 5238 5657 5979 6200 6338 6518 4994 5249 5662 5986 6201 6341 6520 5002 5252 5663 6017 6205 6343 6521 5013 5269 5664 6026 6207 6346 6525 5017 5274 5668 6029 6208 6353 6527 5022 5275 5679 6030 6209 6354 6529 5029 5278 5681 6034 6215 6363 6538 5031 5279 5682 6039 6217 6367 6539 5043 5281 5683 6040 6218 6368 6541 5049 5287 5690 6049 6220 6369 6542 5051 5288 5692 6051 6223 6374 6547 5052 5291 5693 6053 6224 6380 6550 5053 5317 5697 6056 6225 6381 6551 5054 5319 5699 6061 6230 6382 6552 5058 5321 5700 6065 6231 6385 6554 5061 5340 5704 6067 6232 6388 6555 5063 5361 5710 6070 6233 6392 6557 5069 5370 5724 6071 6235 6393 6559 5070 5371 5729 6074 6237 6394 6560 5075 5374 5744 6078 6239 6395 6566 5077 5376 5746 6079 6246 6397 6570 5091 5378 5750 6080 6247 6411 6571 5093 5380 5757 6084 6248 6413 6573 5096 5391 5758 6089 6256 6415 6574 5097 5398 5764 6094 6257 6419 6575
RECALLING FIRM/MANUFACTURER Masimo Corporation, Irvine, CA
REASON Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.
VOLUME OF PRODUCT IN COMMERCE 321 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Stryker PainPump 1 Base Kit; Product number 500-100-000,
b) Stryker PainPump 1 5-Day Infusion Kit; Product number 500-110-000,
c) Stryker PainPump 1 2-Day Infusion Kit; Product number 500-120-000,
d) Stryker PainPump 1 1-Day Infusion Kit; Product number 500-140-000,
e) Stryker PainPump 1 2-Site Y -Connector; Product number 500-200-000,
f) Stryker PainPump 1 2-Site Y -Connector; Product number 500-250-000,
g) Stryker PainPump 1.5 Base Infusion Kit; Product number 501-100-000,
h) Stryker PainPump 1.5 5-Day Infusion Kit; Product number 501-120-000,
i) Stryker PainPump 1.5 2-Day Infusion Kit; Product number 501-140-000,
CODE
a) Lot 2005060702;
b) Lot 2005060701;
c) Lots 2005052002, 2005060703, 2005061401, 2005062001 and 2005063001;
d) Lot 2005051101 and 2005062301;
e) Lot 2005052501;
f) Lot 2005053102;
g) Lot 2005053004;
h) Lots 2005053003 and 2005060301;
i) Lots 2005053001, 2005060203, 2005062702 and 2005051002
RECALLING FIRM/MANUFACTURER Stryker Instruments Div. Of Stryker Corporation, Portage, MI, 
REASON The catheter tubing included in the kit may break during removal.
VOLUME OF PRODUCT IN COMMERCE 2,935 boxes
DISTRIBUTION Nationwide, Australia and Canada

PRODUCT Cook Harrison fetal bladder stent set, sterile; RF J-HFBS-503540,
CODE All units
RECALLING FIRM/MANUFACTURER Cook Urological, Inc, Spencer, IN
REASON Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
VOLUME OF PRODUCT IN COMMERCE 1,300 units
DISTRIBUTION Nationwide and Internationally

PRODUCT AMS Her Option Cryoablation Therapy Disposable Probe her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile, the Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe
CODE Lots 431803 and 436666
RECALLING FIRM/MANUFACTURER American Medical Systems, Minnetonka, MN
REASON Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.
VOLUME OF PRODUCT IN COMMERCE 152 units
DISTRIBUTION Nationwide

PRODUCT General Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control, Catalog number: S1-32, 
CODE
Lot: A31, Exp. 2/2006 (Kit lot #F1458);
Lot A41, Exp.1/2007 (Kit lot # F1757, F1757A, F1757B, and F1757C)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alfa Wassermann, Inc., West Caldwell, NJ
REASON Inaccurate test results. The magnesium values for the A31/A41 General Serum calibrator gave control results that were biased approx. 20% high.
VOLUME OF PRODUCT IN COMMERCE 22,897 kits
DISTRIBUTION Nationwide and the Netherlands

PRODUCT Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only, 
CODE Lot number 1146548
RECALLING FIRM/MANUFACTURER
Recalling Firm: St. Jude Medical/Daig Division, Minnetonka, MN
Manufacturer: St. Jude Medical, Puerto Rico B.V., Caguas, PR,
REASON Mispackaging -- Some Angio-Seal 6F STS Vascular Closure Devices have been incorrectly packaged with a 0.035’ guidewire instead of a 0.032’ guidewire.
VOLUME OF PRODUCT IN COMMERCE 4,160 devices
DISTRIBUTION Belgium, China, Guadalajara, New Zealand and Thailand

PRODUCT Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React®, Pulmonic Valve Conduit, NR4000-PA-C, Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React®' treatment*, INSTRUCTIONS FOR USE, 
CODE
Model NR4000PA-C (size 6 mm), serial# PE19061, Lot # 030804-NR, Aug 2007 expiration
Model NR4000PA-C (size 5 mm), serial# PE19089, Lot # 030924-NR, Sept 2007 expiration
Model NR4000PA-C (size 6 mm), serial# PE20073, Lot # 040903-NR, Sept 2008 expiration
Model NR4000PA-C (size 5 mm), serial# PE20678, Lot # 050222-NR, Feb 2009 expiration
Model NR4000PA-C (size 6 mm), serial# PE20388, Lot # 050103-NR, Jan 2009 expiration
Model NR4000PA-C (size 5 mm), serial# PE20677, Lot # 050222-NR, Feb 2009 expiration
RECALLING FIRM/MANUFACTURER Shelhigh, Inc., Union, NJ
REASON Unapproved Device-Distribution of an unapproved device into interstate commerce.
VOLUME OF PRODUCT IN COMMERCE 25 units
DISTRIBUTION MA, AZ, and Italy

PRODUCT
a) Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module
(5M3052/5M3052R), with a cart with scales (5M3053); product code GEF042-10 in China, 
b) Baxter BM11A Blood Monitor Pump hemodialysis machine; product code 5M3051, 5M3051R, c) Baxter BM11 Blood Monitor Pump hemodialysis machine; product code 5M3005, 5M3005R, CODE All Serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL
Manufacturer: Mesys Gmbh. Hannover. Germany, 
REASON Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM 11/BM 11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.
VOLUME OF PRODUCT IN COMMERCE 1,249 units
DISTRIBUTION Nationwide, Colombia, Hong Kong and China

PRODUCT
a) Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases,
electrolyte and blood pH test system, 
b) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---Common Name: Blood gases, electrolyte and blood pH test system,
c) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---Common Name: Blood gases, electrolyte and blood pH test system,
d) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. ---Common Name: Blood gases, electrolyte and blood pH test system,
CODE All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY,
Manufacturer: Bayer Healthcare, LLC (Diagnostics Division), Norwood, MA, 
REASON When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.
VOLUME OF PRODUCT IN COMMERCE 515 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Tooth bonding resin. Optibond Solo Plus, Part number 31513, 
b) Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part number 31514, 
c) Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part number 31736, 
d) Tooth bonding resin. Nexus 2 Kit, Part number 31954, 
e) Tooth bonding resin. Nexus 2 Starter Kit, Part number 31955, 
f) Tooth bonding resin. Premise Master Syringe Kit, Part number 32611, 
g) Tooth bonding resin. Premise Master Unidose Kit, Part number 32612, 
h) Tooth bonding resin. Premise Starter Unidose Kit, Part number 32684, 
CODE
a) Lot numbers: 427936. 428569, and 428290;
b) Lot number: 429106;
c) Lot number: 427793;
d) Lot number: 428572;
e) Lot numbers: 428570 and 429640;
f) Lot number: 428730;
g) Lot number: 428576;
h) Lot number: 427915
RECALLING FIRM/MANUFACTURER Kerr Corporation, Orange, CA
REASON The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
VOLUME OF PRODUCT IN COMMERCE 7,320 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT110, 
b) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT111, 
c) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT210, 
d) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated,
Catalogue Number RT211, 
CODE Affected lots for all catalogue numbers: 041101-050331 (inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, 
Manufacturer: Fisher and Paykel Ltd., Auckland, New Zealand,
REASON Risk of fire, The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
VOLUME OF PRODUCT IN COMMERCE 5,475 boxes (54,750 pcs)
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Osteofil + RT Allograft Paste 10cc. SINGLE PATIENT USE ONLY,
b) Osteofil Allograft, 5cc, SINGLE PATIENT USE ONLY,
c) Osteofil Allograft Paste (Bio) of varying sizes, SINGLE PATIENT USE ONLY,
d) Osteofil IC Syringeable of varying sizes. SINGLE PATIENT USE ONLY,
e) Osteofil ICM Moldable Strip of varying sizes. SINGLE PATIENT USE ONLY,
f) Osteofil RT, ICM Allograft Paste in varying sizes. SINGLE PATIENT USE ONLY,
CODE
a) 1766813 1766814 1890442 1890445 1890446 1890447 1890450 1890451 1938863 1938864 1938865 1938868 1938869 1890448 1890449 1938862 1938866 1938870;
b) 1678712 1678713 1678714 1678715 1678716 1678718 2086922 2086924 2086925 2115381 2115382 2115383 2115384 2115385 2115387 2115388 2115389 2115390 2116581 2116582 2116585 2116586 2116587 2116588 2116589 2116590 2116762 2116764
2116766 2116767 2116768 2116771 2116892 2116893 2116894 2116895 2116896 2116897 2116898 2116899 2116900 2116901 1678711 1678717 1678719 1678720 2086921 2086923 2115386 2116583 2116584 2116763 2116765 2116769 2116770;
c) 1760901 1760902 1760903 1760905 1760906 1760907 1760908 1760909 1765751 1765752 1765753 1765754 1765755 1765756 1765759 1765760 1765781 1765782 1765783 1765784 1765785 1765787 1765789 1776411 1776413 1776414 1776415 1776417 1776418 1776419 1776420 1793211 1793212 1793215 1793217 1793218 1793219 1793220 1793462 1793463 1793464 1793465 1793466 1793467 1793468 1793469 1793470 1827001 1827002
1827003 1827004 1827006 1827008 1827009 1827010 1827311 1827312 1827313 1827314 1827316 1827318 1827319 1827320 1760904 1765757 1765758 1765786 1765788 1765790 1776412 1776416 1793213 1793214 1793216 1793461 1827005 1827007 1827315 1827317 1672181 1672182 1672183 1672184 1672185 1672186 1672187 1672188 1672190 1672241 1672243 1672244 1672245 1672247 1672248 1672249 1672250 1672393 1672394 1672395 1672397 1672400 1672431 1672433 1672434 1672435 1672436 1672438 1672439 1672471 1672473 1672474 1672475 1672476 2185771 2185773 2185775 2185961 2185963 2185964
2185965 2185966 2185967 2185968 2185970 2197196 2197197 2197198 2197199 2197200 2197201 2197202 2197203 2197484 2197485 2197487 2197488 2197489 2197491 2197493 1672189 1672242 1672246 1672396 1672432 1672437 1672440 1672472 2185772 2185962 2185969 2197194 2197195 2197486 2197490 2197492 2141130 2141132 2141133 2141134 2141135 2141137 2141138 2141139 2141140 2141141 2141143 2141144 2141145 2250214 2250215 2250216 2250218 2250219 2250220 2250221 2250223 2250224 2250225 2250226 2250227 2250228 2250229 2250232 2250233 2250234 2250235 2250236 2250237 2250240
2250261 2250262 2250263 2250264 2250265 2517551 2517556 2517557 2522091 2522098 2522099 2141127 2141128 2141129 2141131 2141136 2141142 2250212 2250213 2250217 2250222 2250230 2250231 2250238 2250239 2517552 2517553 2517554 2517555 2517558 2517559 2517560 2521551 2521552 2521553 2521554 2521555 2521556 2522092 2522093 2522094 2522095 2522096 2522097 2522100;
d) 2185721 2185722 2185723 2185726 2185727 2185728 2185941 2185942 2185943 2185947 2185949 2185950 2250244 2185724 2185725 2185729 2185730 2185944 2185945 2185946 2185948 2141102 2141104 2141106 2141107 2141108 2141109 2141111 2141112 2141113 2141114 2141115 2141116 2141118 2141119 2141120 2141122 2141123 2141124 2141125 2141126 2157937 2157938 2157939 2157940 2157941 2157943 2157944 2157945
2141103 2141105 2141110 2141117 2141121 2157942 2157946 2250241 2250242 2250243;
e) 1662221 1662222 1662224 1662225 1662226 1662228 1662229 1662230 1672261 1672262 1672263 1672264 1672265 1672266 1672267 1672268 1672269 1672270 2085436 2091131 2091132 2091133 2091135 2091136 2091137 2091138 2091140 2094702 2094703 2094704 2094705 2094706 2094709 2207921 2207922 2207925 2207926 2207927 2207930 2724041 2724042 2724043 2724045 2724048 1662223 2091134 2091139 2094701 2094707
2094708 2094710 2207923 2207924 2207928 2207929 2724040 2724044 2724046 2724047 2193437 2193438 2193439 2197304 2197305 2197307 2197308 2197309 2197310 2197311 2197313 2290771 2290772 2290774 2290775 2290776 2290777 2290778 2290779 2290780 2291312 2291313 2291314 2291315 2291316 2291317 2291319 2291320 2774214 2774217 2774218 2193436 2197306 2197312 2290773 2291311 2291318 2774213 2774215 2774216;
f) 2014947 2014949 2014952 2014953 2014954 2091152 2091153 2091154 2326261 2326262 2326263 2326265 2326267 2326268 2326269 2326270 2326761 2326762 2326764 2326767 2326769 2326770 2326801 2326802 2326803 2326804 2326805 2326806 2326806 2326807 2326808 2326809 2389440 2395012 2395013 2395014 2395015 2395016 2395017 2395018 2395019 2014945 2014946 2014948 2014950 2014951 2091151 2326264 2326763
2326765 2326766 2326810 2395011 2395020 2171680 2171681 2171682 2171683 2171684 2171685 2171686 2171687 2171688 2171690 2171692 2171693 2171694 2171695 2171696 2171697 2171698 2171700 2171702 2171703 2171704 2171705 2171706 2171707 2171708 2171709 2171710 2171711 2171712 2171713 2171689 2171691 2171699 2171701
RECALLING FIRM/MANUFACTURER Regeneration Technologies, Inc., Alachua, FL
REASON The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
VOLUME OF PRODUCT IN COMMERCE 554 units
DISTRIBUTION TN

WEEK ENDING APRIL 15

PRODUCT
a) Stryker Epic Critical Care Bed, Model 2030,
b) Stryker Epic Zoom Critical Care Bed, Model 2040,
CODE
a) Serial numbers 0512068638, 0512068639, 0512068640, 0512068641,
0512068642, 0512068667, 0512068668, 0512068669, 0512068670, 0512068725, 0512068726, 0512068727, 0512068728, 0512068740, 0512068750, 0512068751, 0409060679, 0409060680, 0409060681, 0409060682, 0409060683, 0409060684, 0409060685, 0409060686, 0409060687, 0512068643, 0512068644, 0512068645, 0512068646, 0512068647, 0512068648, 0512068649, 0512068650, 0512068651, 0512068652, 0512068653, 0512068654, 0512068655, 0512068656, 0512068657, 0512068658, 0512068659, 0512068660, 0512068661, 0512068662, 0512068779, 0512068780, 0512068781, 0512068782, 0512068783, 0512068784, 0512068785, 0512068709, 0512068710, 0512068711, 0512068712, 0512068713, 0512068714, 0512068715, 0512068716, 0512068717, 0512068718, 0512068719, 0512068720, 0512068721, 0512068722, 0512068723 and 0512068724;
b) Serial numbers 0512068663, 0512068664, 0512068665, 0512068666,
0512068681, 0512068682, 0512068741, 0512068742, 0512068743, 0512068744, 0512068745, 0512068746, 0512068747, 0512068748, 0512068749, 0512068762, 0512068763, 0512068759, 0512068760, 0512068764, 0512068765, 0512068766, 0512068767, 0512068768, 0512068769, 0512068770, 0512068771, 0512068772, 0512068773, 0512068774, 0512068775, 0512068776, 0512068777, 0512068778, 0601085035, 0601085036, 0601085064, 0601085141, 0601085142, 0601085143,0512068671, 0512068672, 0512068673, 0512068674, 0512068675, 0512068676, 0512068677, 0512068678, 0512068679 and 0512068680
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI
REASON The bed exit may not alarm as appropriate.
VOLUME OF PRODUCT IN COMMERCE 118 beds
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Fischer Cone Biopsy Excisor – Small Model: 900-150,
b) Fischer Cone Biopsy Excisor - Medium Model: 900-151,
c) Fischer Cone Biopsy Excisor – Large Model: 900-152,
d) Fischer Cone Biopsy Excisor – Medium - Ext Model: 900-154,
e) Fischer Cone Biopsy Excisor – Large - Shallow Model: 900-155,
f) Fischer Cone Biopsy Excisor – Dual Sets Model: 900-156,
g) Fischer Cone Biopsy Excisor – Model: 900-157,
h) Fischer Cone Biopsy Excisor – Model: 900-158, 
CODE
a) Lot Numbers: A2001, D201702, D209314, D211316, D218411,D220313, D225216, D230104, D301326, D302104 C143D, C213H, D307908, D313505, E193, D316303 G293, H213, I153C, J283, K063L, L153N, A134F;
b) Lot Numbers: D201704, A2002, D201705, D201703, D205001, D209315, D211317, D218412, D217007, D220314, D224801, D232202, D301327, D302105, D304805, C143E, C213G, D307906, D093H, D311206, D313506 E193A, D316304, D318111, H213A, I153B I153, J073A, J283A, K063M, L043A, L153O A024, A134E;
c) Lot Numbers: D201706, D201708, D205002, A2003, D211318, D218914, D217008, D223910, D223910, D232504, D233021, D302103, C143F, C213F, D307907, D093K, D310620, E193B, D316305, G303A, H213B, J073B, K063N, L043B, L153P, A134D;
d) Lot Numbers: D201709, D201707, D205003, A2004, D211319, D225404, D233020, C143G, D307909, D310619, D316306, H213C, I153A, J283B, L043C, A134C, A304;
e) Lot Numbers: D201710, A2005, D205004, D218913, D229701, D304806, D307910, D316307, H213D, J073C, L153Q, A134B;
f) Lot Numbers: D201711, D202712, D205005, A2010, D217006, D233019, D093J, D313507, H223F, J073D, L043D, A234I;
g) Lot Numbers: A2006, D205006;
h) Lot Numbers: A2007, D205007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apple Medical Corporation, Marlborough, MA
Manufacturer: Geotec, Inc., Warwick, RI
REASON Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to e retrieved from patient.
VOLUME OF PRODUCT IN COMMERCE 94,000 boxes
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Gambro Prisma M100 preset
b) Gambro Prisma HF1000 preset
CODE
a) Lot numbers: 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865,
05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G,
05G0556G, 05G0760G, 05G1366G;
b) Lot number: 05F0864P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO
Manufacturer: Gambro Hospal Industrie, Meyzieu Cedex (Lyon), France
REASON After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
VOLUME OF PRODUCT IN COMMERCE 29,942 units
DISTRIBUTION Nationwide and Internationally

PRODUCT ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts
CODE Lot number: 1211723, expiration date: Nov 2007
RECALLING FIRM/MANUFACTURER Ev3, Plymouth, MN
REASON Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
VOLUME OF PRODUCT IN COMMERCE 4 stents
DISTRIBUTION GA, OK, and TX

PRODUCT Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Catalog Numbers: EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fujinon, Inc., Wayne, NJ
Manufacturer: Fujinon Corporation, Saitama, Japan.
REASON Colonoscope insertion tube is not bending properly and is stiff.
VOLUME OF PRODUCT IN COMMERCE 2,335 units
DISTRIBUTION Nationwide and Canada

PRODUCT Lifepak 12 defibrillator/monitor
CODE Domestic Serial Numbers: 33884879, 33884872, 33884912, 33884871, 33884867, 33884866, 33829105, 33829090, 33950589, 33911492, 33946302, 33884898, 33951494, 33980272, 33986554, 33818744, 33818718, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33900980, 33980275, 33980280, 33980287, 33980281, 33819680, 33829407, 33971829, 33986933, 33967385, 34011822, 34011819, 33894426, 33894572, 33900981, 33936889, 33884924, 33826068, 33981789, 33981799, 33981792, 33981805, 33981794, 33981796, 33981793, 33981795, 33981797, 33959538, 33938363, 34011821, 33894425, 33959550, 33938924, 33938921, 33922299, 33930122, 33933904, 33826017, 33955760, 33897337, 33955747, 33951295, 33951456, 33976455, 33951447, 33951275, 33979473, 33979470, 33979471, 33979472, 33979474, 33979469, 33976420, 33976429, 33976413, 33976414, 33976415, 33976416, 33976411, 33976418, 33976410, 33976424, 33976426, 33976427, 33976417, 33976412, 33976430, 33976406, 33976407, 33976408, 33976428, 33976431, 33976419, 33933878, 33946268, 33946277, 33897329, 33905622, 33905621, 33905609, 33911477, 33911470, 33911450, 33911449, 33911446, 33905590, 33905585, 33905581, 33911571, 33897342, 33897320, 33897322, 33905514, 33911528, 33911627, 33905518, 33955832, 33955765, 33955759, 33951605, 33951484, 33951059, 33951467, 33951473, 33951487, 33955761, 33894580, 33905444, 33951128, 33950588, 33951434, 33951273, 33951287, 33951551, 33826023, 33826022, 33826009, 33826008, 33826005, 33826003, 33826021, 33915964, 33915884, 33922357, 33911587, 33986931, 33997554, 33971953, 33955806, 33955833, 33826029, 33951560, 33955752, 33951589, 33951588, 33951586, 33951585, 33951583, 33951576, 33951595, 33951569, 33951580, 33951604, 33955751, 33955748, 33951592, 33951593, 33951601, 33951600, 33951599, 33951598, 33951597, 33951582, 33951409, 33951403, 33951293, 33951292, 33951468, 33951462, 33951553, 33951552, 33951535, 33951497, 33951518, 33959570, 33946296, 31014367, 33997567, 33904931, 33904929, 33904928, 33904926, 33904923, 33904921, 33904936, 33904917, 33904914, 33904913, 33904910, 33904922, 33905443, 33905441, 33905440, 33905434, 33905432, 33904933, 33905430, 33904932, 33905427, 33904938, 33904937, 33904876, 33905470, 33905488, 33905474, 33905473, 33901782, 33901777, 33901773, 33901771, 33901770, 33905451, 33901787, 33901762, 33901753, 33901761, 33911601, 33915916, 33915917, 33915910, 33915961, 33959578, 33959606, 33897319, 33905516, 33905507, 33922294, 33911635, 33911634, 33911632, 33911631, 33911611, 33911624, 33911614, 33917454, 33917452, 33917448, 33917447, 33917444, 33917443, 33917440, 33894289, 33905521, 33905520, 33917455, 33917453, 33917470, 33921055, 33921053, 33921052, 33921050, 33921049, 33921047, 33921046, 33917468, 33917467, 33917466, 33917465, 33917464, 33917463, 33917461, 33917457, 33917456, 33921045, 33955771, 33955762, 33955750, 33951603, 33986555, 33986346, 33986324, 33979488, 33980264, 33986878, 33986897, 33981778, 33169330, 33904924, 33911468, 33905495, 33905496, 33905459, 33905587, 33905497, 33933906, 33901735, 33894413, 33955802, 33955839, 33955831, 33955829, 33955827, 33955803, 33938926, 33951596, 33951426, 33951405, 33997552, 33986873, 33986877, 33905438, 33924704, 33904878, 33901737, 33950587, 33951298, 33951283, 33976463, 33980266, 33980290, 33980294, 33980278, 33980279, 33980291, 33980285, 33980301, 33980304, 33986548, 33976478, 33976479, 33976485, 33976477, 33976468, 33976470, 33976471, 33976456, 33976446, 33976447, 33819634, 33947249, 33947931, 33947264, 33915931, 33915930, 33915929, 33915928, 33915925, 33915889, 33915887, 33915888, 33915899, 33915898, 33915897, 33915895, 33915894, 33915893, 33915892, 33915890, 33911603, 33911602, 33911597, 33936877, 33936874, 33915914, 33915919, 33915922, 33915912, 33915911, 33915908, 33980268, 33980300, 33986563, 33986561, 33986564, 33986565, 33986562, 33986543, 33986351, 33986330, 33986342, 33986349, 33986348, 33986345, 33986338, 33986344, 33971910, 33971905, 33971901, 33971838, 33897350, 33897344, 33884882, 33884875, 33884911, 33990265, 34015699, 31368552, 33986913, 33911532, 33911535, 33936914, 33971950, 33894290, 33911625, 33986559, 33986549, 33986551, 33986323, 33911595, 33915885, 33933909, 33826019, 33826001, 33825999, 33826000, 33823372, 33823373, 33823375, 33823342, 33823340, 33823348, 33823367, 33823366, 33823358, 33823356, 33829111, 33823382, 33823386, 33823381, 33823378, 33823384, 33951602, 33951449, 33986558, 33986556, 33986553, 33986325, 33986339, 33818733, 33951572, 33951568, 33951439, 33951556, 33980297, 33897327, 33980274, 33915956, 33826048, 33951476, 31388033, 33905592, 33905589, 33990271, 34011832, 33933911, 33905582, 33894597, 33955840, 33915926, 33915939, 33933931, 33884958, 33997573, 33997566, 33946303, 33930103, 33924697, 33924699, 33924696, 33924695, 33924703, 33924705, 33924706, 33924692, 33930102, 33930105, 33897353, 33924701, 33818749, 33946314, 33930107, 33924684, 33924682, 33955755, 33986911, 34011824, 34017741, 33980296, 33986546, 33986334, 33986343, 33986335, 33986337, 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International Serial Numbers: 33947246, 33947247, 33890408, 33892605, 33790557, 33819595, 33819594, 33894427, 33826015, 33823319, 33823313, 33946278, 33933874, 33946270, 33933948, 33933865, 33933882, 33950568, 33933892, 33933893, 33933895, 33933887, 33933912, 33933913, 33933898, 33933889, 33930119, 33933884, 33826079, 33819604, 33905620, 33823314, 33946287, 33889422, 33892602, 33884927, 33884920, 33884935, 33894575, 33894408, 33894407, 33894595, 33894576, 33905610, 33905613, 33911432, 33905605, 33950445, 33915942, 33915932, 33922354, 33915948, 33915934, 33819610, 33823315, 33946291, 33946292, 33946294, 33946295, 33976467, 33946290, 33881436, 33986796, 33986798, 33986801, 33959551, 33959548, 33976462, 33959557, 33979559, 33986803, 33976405, 33976466, 33980269, 33955843, 33986812, 33986813, 33955783, 33980292, 33976473, 33976469, 33986875, 33976438, 33976439, 33986805, 33946309, 33976442, 33986806, 33976444, 33976484, 33980284, 33976449, 33986810, 33890389, 33890402, 33890398, 33890397, 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33881358, 33881357, 33881356, 33881355, 33881364, 33881374, 33881380, 33881379, 33881376, 33884909, 33881450, 33881445, 33884886, 33884884, 33884894, 33819598, 33819606, 33819608, 33829152, 33829149, 33829154, 33829153, 33829150, 33829148, 33819592, 33829146, 33829144, 33819596, 33932689, 33894390, 33894389, 33892593, 33894571, 33894386, 33932679, 33881331, 33894388, 33881354, 33881353, 33881352, 33881351, 33881350, 33881333, 33881330, 33881329, 33881327, 33830738, 33881349, 33894385, 33894384, 33894383, 33894381, 33894291, 33904919, 33826060, 33826072, 33818791, 33818742, 33818787, 33819655, 33819643, 33819667, 33819635, 33823336, 33823324, 33823331, 33823317, 33946282, 33933937, 33898446, 33898432, 33933944, 33894554, 33898435, 33898436, 33933942, 33933869, 33932741, 33933870, 33933868, 33933876, 33933872, 33933858, 33932744, 33946269, 33933863, 33933861, 33950583, 33950446, 33950449, 33950574, 33947930, 33921056, 33921048, 33921054, 33933886, 33947883, 33947886, 33936902, 33947875, 33894596, 33980270, 33980299, 33986794, 33976425, 33955823, 33959553, 33959545, 33959544, 33979505, 33991489, 33991484, 33991483, 33991478, 33991494, 33991477, 33991499, 33890401, 33890400, 33890399, 33890405, 33889503, 33889502, 33889501, 33889500, 33889499, 33890424, 33890413, 33890422, 33890421, 33890420, 33890418, 33890416, 33890414, 33890412, 33890411, 33890410, 33889496, 33890415, 33889428, 33889498, 33889486, 33889495, 33889494, 33889493, 33889492, 33889491, 33889490, 33889489, 33889487, 33889484, 33889483, 33889480, 33889479, 33889477, 33892588, 33889488, 34003578, 34003565, 33997578, 33997575, 34003593, 33890423, 34011834, 34022211, 34015723, 34011708, 34011705, 34011703, 34011696, 34003592, 34011829, 34011813, 33892603, 33892601, 33892595, 33892594, 33892590, 33892599, 33981790, 33959608, 33959607, 33959600, 33959566, 33892611, 33881407, 33881416, 33881415, 33881414, 33881412, 33881395, 33881419, 33881405, 33881400, 33881398, 33881397, 33881428, 34022212, 33881435, 33946286, 33881433, 33881432, 33881431, 33881417, 33881429, 33881427, 33881426, 33881425, 33881424, 33881423, 33881420, 33881430, 33881370, 33881368, 33881365, 33881392, 33881391, 33881390, 33881389, 33881388, 33881387, 33881386, 33881373, 33881384, 33881382, 33881381, 33881378, 33881377, 33881385, 33884917, 33884910, 33884908, 33884942, 34022198, 33884948, 33884946, 33884931, 33884938, 33884936, 33884934, 33884902, 33884944, 33884904, 33884874, 33884870, 33881455, 33881454, 33881453, 33884878, 33881451, 33881449, 33881448, 33881447, 33881446, 33881443, 33881442, 33881452, 33884892, 33881440, 33884901, 33884899, 33884897, 33884896, 33884903, 33884890, 33884888, 33884887, 33884881, 33829395, 33819600, 33819601, 33819607, 33819597, 33819613, 33829409, 33829406, 33829405, 33829404, 33829403, 33829401, 33819609, 33829399, 33829398, 33829396, 33829128, 33829402, 33829142, 33819588, 33829132, 33829131, 33829130, 33819586, 33829143, 33829410, 33814240, 33814239, 33829393, 33829392, 33819589, 33819590, 33829147, 33819591, 33819593, 33819614, 33930108, 33930115, 33932678, 33894551, 33830737, 33830736, 33829411, 33924700, 33826093, 33826077, 33826078, 33826080, 33826082, 33826083, 33823374, 33826085, 33826086, 33826089, 33826033, 33826092, 33826073, 33826094, 33829140, 33823361, 33819605, 33819603, 33819602, 33823380, 33819676, 33826039, 33829093, 33826043, 33829089, 33826049, 33826050, 33823383, 33826074, 33826058, 33826062, 33826063, 33826064, 33826065, 33826066, 33826067, 33826070, 33826071, 33817019, 33818757, 33818756, 33818748, 33818745, 33818740, 33818737, 33818725, 33818761, 33818763, 33818790, 33818789, 33818788, 33818786, 33818785, 33818784, 33818782, 33818759, 33818780, 33818775, 33818773, 33818772, 33818770, 33818769, 33818768, 33818766, 33818764, 33818781, 33819646, 33819648, 33819649, 33819650, 33829125, 33819652, 33819654, 33819656, 33826034, 33819660, 33819661, 33829124, 33819664, 33829123, 33819666, 33829122, 33829121, 33819670, 33819671, 33819617, 33819618, 33819620, 33819622, 33819624, 33819627, 33819645, 33819629, 33819631, 33819632, 33829127, 33829126, 33819638, 33819641, 33819674, 33819628, 33829120, 33829115, 33829114, 33826002, 33829110, 33826006, 33829106, 33826011, 33823334, 33826014, 33823333, 33826016, 33829102, 33826020, 33826025, 33826026, 33829097, 33826028, 33826031, 33826012, 33819675, 33819677, 33819679, 33829118, 33829117, 33823335, 33819673, 33823322, 33823325, 33823326, 33823328, 33823329, 33823330, 33823332, 33922359, 33946280, 33946283, 33933954, 33933952, 33933953, 33900686, 33933939, 33933955, 33933938, 33894553, 33933946, 33898429, 33898431, 33898449, 33933956, 33898441, 33898442, 33933941, 33924678, 33929476, 33924669, 33929477, 33922368, 33922367, 33933867, 33922370, 33922376, 33946267, 33933947, 33922382, 33922378, 33929479, 33933860, 33946273, 33922363, 33946276, 33933949, 33933950, 33922364, 33933864, 33933866, 33951115, 33950582, 33950585, 33950586, 33951064, 33951074, 33951116, 33951117, 33951119, 33951120, 33951123, 33951125, 33951084, 33951132, 33924676, 33951126, 33922375, 33924662, 33924665, 33924666, 33924671, 33924672, 33924674, 33922295, 33924680, 33924683, 33924691, 33930141, 33930100, 33930099, 33924673, 33915933, 33932722, 33947926, 33915943, 33915957, 33915960, 33933902, 33933891, 33933897, 33933903, 33930120, 33930123, 33933883, 33933885, 33947895, 33947891, 33947906, 33947911, 33947914, 33947918, 33947928, 33938358, 33938361, 33947880, 33947876, 33894387, 33979498, 33979556, 33979520, 33976422, 33933881, 33946310, 33889471, 33881371, 33884922, 33894568, 33894588, 33894581, 33894579, 33884928, 33826076, 33915902
RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond, WA, 
REASON Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
VOLUME OF PRODUCT IN COMMERCE 942 Lifepak 12 devices; 2678 Lifepak 20 devices

DISTRIBUTION Nationwide and Internationally

*****CORRECTION*****

The serial numbers listed for (Lifepak 12) are the serial numbers for  (Lifepak 20). See correct Codes below:

PRODUCT
a) Lifepak 12 defibrillator/monitor
b) Lifepak 20 defibrillator/monitor
CODE
a) Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 34087619, 34087620, 34087605, 34087610, 34087612, 34087035, 34087892, 34087602, 34087615, 34087616, 34087617, 34087618, 34086700, 34086709, 34086715, 34087613, 34086714, 34087609, 34087607, 34087614, 34087608, 34086718, 34086706, 34086719, 34086711, 34086713, 34086705, 34086717, 34086702, 34087606, 34086703, 34087033, 34086708, 34086712, 34087603, 34086707, 34087604, 34086716, 34087601, 34087034, 34091720, 33949930, 34091120, 34039430, 34039429, 34015786, 34011974, 33982989, 33899585, 33995356, 33995351, 33995350, 33995346, 33995360, 33995355, 33995369, 33995349, 33995348, 33995352, 33995347, 33995359, 33995353, 33995345, 33995358, 33995354, 12737672, 33913878, 34094631, 34049603, 34049601, 34049604, 34049611, 34049606, 34049607, 34049609, 34049612, 34049608, 34049610, 34049605, 34049602, 30859396, 33978921, 33978922, 33978923, 33978924, 34039468, 34039433, 34039470, 34083705, 34096379, 33915357, 33988150, 33992032, 33931367, 33931365, 33931364, 33931363, 33931362, 33931366, 34052702, 34052703, 33795379, 34095303, 34095298, 34095299, 34095304, 34095300, 34096375, 34095314, 34095313, 34095312, 34095307, 34095306, 34095305, 33862271, 34019587, 34020177, 34019586, 34019585, 34090338, 34090337, 34049130, 34043663, 34086675, 34086676, 34086671, 34086672, 34086674, 34086673, 33832318, 33888386, 33888372, 33888377, 33888376, 33888378, 33888379, 33888383, 33888385, 33888384, 33888373, 34044798, 34064654, 34019555, 34019554, 33802295, 33990042, 33982418, 33982417, 34074060, 34074061, 34095296, 34039463, 33950592, 33983052, 34099021, 34095323, 34082638, 34078647, 34078648, 34078646, 34082590, 34082591, 34048199, 34048200, 34049140, 34049141, 34048196, 34048198, 34045124, 34048194, 34010325, 33899587, 34096386, 34074089, 33974887, 33974888, 34078076, 34100491, 34100492, 34099179, 34099180, 34099178, 34099177, 34099176, 34090571, 34067899, 33995913, 33995914, 33974374, 33974373, 34013030, 34083205, 34019584, 10732394, 10732404, 34079488, 34084291, 34084290, 34004900, 34019558, 34019561, 33913867, 33913879, 33913888, 33995281, 33995280, 34090554, 34090556, 34090555, 34052280, 33991462, 34065273, 34048197, 34048195, 34034132, 34004904, 34082921, 34060126, 34060127, 34060128, 34086704, 34086701, 34086710, 33992506, 34074081, 34074073, 33855207, 33995302, 33995301, 34054626, 34054625, 33904163, 12776983, 33997196, 33987972, 33987973, 33928602, 34010320, 33974366, 34095302, 33938189, 34040207, 34039481, 34060174, 34060158, 34060161, 34060160, 34064667, 34003616, 34039469, 34060746, 34034134, 34106173, 33995035, 34074053, 34010323, 34090366, 34087611, 34090303, 34090302, 34091128, 34091129, 34095293, 33897593, 34078783, 34078784, 34078785, 34074072, 33992007, 33992020, 33993956, 33992022, 33992002, 33992021, 33992024, 33992025, 33992026, 33992004, 33992009, 33992015, 33992001, 33990248, 33992006, 33992005, 33992008, 33992014, 33992018, 33992017, 33990243, 33990246, 33990247, 33992011, 33992012, 33992013, 33992019, 33992010, 34019904, 33899702, 33960797, 33960796, 33960799, 33960798, 33960795, 33995049, 34061036, 34090589, 33931359, 33931358, 33931355, 33931356, 33931357, 34079490, 34079489, 34079833, 34079492, 34079491, 34079487, 34079486, 34079485, 33936114, 34068040, 34068041, 34078675, 33925842, 33925844, 33925846, 33925841, 33925843, 33925845, 33935283, 33935282, 33935281, 33935280, 33928109, 34090546, 34039464, 34082588, 33911101, 33911100, 33965863, 34074054, 34070493, 33997671, 33997672, 34078070, 34064659, 33996557, 33996553, 33996551, 33996550, 33996556, 33996549, 33996849, 33996558, 33996554, 33996552, 33993444, 34095321, 34095327, 34095331, 34095330, 34095326, 34095329, 34095320, 34095324, 34095328, 34095322, 33983339, 33976090, 33983346, 33983345, 33983338, 33983337, 33983336, 33983335, 32525390, 33995263, 34020191, 34019826, 34019557, 34019827, 34019556, 13583628, 34005592, 34005591, 34005587, 34005588, 34005589, 34005590, 33969580, 33969582, 33969581, 33969583, 33969584, 33995222, 34045762, 34099186, 34099185, 33991446, 33903858, 33997197, 34084471, 34075613, 34075614. International Serial Numbers: 34098600, 34098601, 34090290, 34049509, 34049514, 34049515, 34083701, 34083702, 34044802, 33982442, 33982438, 33982439, 33934527, 33903205, 33903206, 33903208, 33903204, 33903198, 33903203, 33903207, 33903201, 33903210, 33903202, 33903199, 33903200, 33934528, 33934531, 33934529, 33934526, 33934530, 33928168, 33903217, 33928174, 33928165, 33982454, 33982437, 33982443, 33982440, 33903216, 33903215, 33982453, 33982452, 33982451, 33982450, 33982441, 33982448, 33982447, 33982446, 33982445, 33982444, 33982449, 33903209, 33928169, 33928160, 33928161, 33928162, 33928164, 33928170, 33928171, 33928172, 33928173, 33928175, 33928176, 33928177, 33928167, 33903211, 33903212, 33903213, 33903214, 33928159, 33950039, 33950038, 33950048, 33952773, 33952774, 33952775, 33952771, 34105152, 33950032, 33876945, 33876930, 33821315, 33876931, 34078216, 33876941, 33876943, 33876942, 33876938, 33876944, 33876952, 33876928, 33876946, 33876951, 33876950, 33876948, 33876940, 33876933, 33876935, 33876936, 33876937, 33950037, 33929937, 33950034, 33950043, 33950042, 33950041, 33950040, 33950053, 33950052, 33950051, 33950049, 33950045, 33950046, 33950047, 33950035, 33950050, 33950054, 33876949, 33876947, 33876939, 33876934, 33876932, 34079098, 33876929, 33950044, 33950033, 33950031, 33950030, 33950036, 34078082, 34078078, 34078081, 34078080, 34079097, 34083393, 34078079, 33985301, 33985300, 33985299, 33985307, 33986568, 33952772, 34079096, 34078215, 34078217, 34078225, 33982471, 33985298, 33985303, 33985304, 33986537, 33985302, 34009595, 34009594, 34009593, 34083729, 34083732, 34077752, 34106204, 34091376, 13669402, 33928605, 33985022, 33983183, 33979582, 33979583, 33974289, 33974293, 33952829, 33952830, 33798619, 33913915, 33798616, 33913909, 33918168, 33918735, 33918736, 33872713, 33918165, 33918166, 33918167, 33918181, 33795390, 33798614, 33896029, 33887441, 33798612, 33795399, 33795397, 33932561, 34094348, 34094349, 34091746, 33986283, 34039425, 33986294, 33983009, 33795389, 33983184, 33983178, 33983010, 33961531, 34074827, 34087714, 33974286, 34049521, 34049526, 34049527, 34049528, 34049529, 34049530, 34053704, 34049523, 33913897, 33913904, 34008743, 34008737, 34003664, 34003634, 34020680, 34020681, 34020164, 34020510, 34034118, 34034725, 33983556, 33974288, 33974287, 33979581, 33974290, 33974291, 34049522, 33983555, 33983554, 33979580, 33974229, 33974292, 33986320, 33913913, 34049520, 33986261, 33974295, 34053733, 34049525, 34053699, 34049524, 33913899, 33913900, 33913901, 33913902, 33985306, 33913905, 34069183, 33985305, 33913898, 33913903, 33913906, 33986313, 33986285, 34003817, 34049519, 34003650, 34003796, 34004911, 34008686, 34008744, 34008742, 34008740, 34008739, 34008738, 34008687, 34008745, 34008741, 34003658, 34020516, 34084458, 34084468, 34074427, 34084092, 34087711, 34087496, 33937399, 33937400, 33937398, 34090742, 33937401, 33937404, 34074835, 33937402, 34083715, 33937403, 33937397, 34090743, 33937405, 33910410, 33910411, 34090741, 34083714, 34044811, 34044812, 34039416, 34074102, 33979590, 34074107, 33983550, 34039419, 34073371, 34039413, 33958404, 33958774, 34074106, 33855054, 33921591, 33921592, 33880013, 33880012, 33880011, 33895654, 33900603, 33899646, 33895655, 33961098, 33961097, 33978886, 34074101, 34106223, 33973952, 33978885, 33979004, 33978888, 33978887, 33983551, 34039415, 34039409, 34039408, 33979564, 33979567, 34079036, 33895653, 33895652, 33895651, 33895650, 33895649, 33893664, 33892562, 33945926, 34074108, 34064246, 34039418, 33895656, 34064247, 34074105, 33968953, 34074099, 34074595, 34074596, 34074104, 34074098, 33949217, 33968972, 33969016, 34074103, 34008392, 34039421, 34012451, 34039422, 34040777, 34040525, 33969015, 34039406, 33968973, 34039405, 33968970, 33968962, 33968966, 33968964, 33969014, 34039407, 33968968, 34034122, 34034124, 34034127, 34034129, 34073370, 33983559, 34073365, 34073366, 34073376, 34065724, 34073364, 33905086, 33905087, 33905088, 33905089, 34003929, 34073369, 34073372, 34073373, 34073374, 34073375, 33968961, 33968963, 33983561, 34079035, 34043644, 34079040, 34079039, 34079037, 34073368, 34073367, 34073363, 34079038, 33928097, 34039410, 34043602, 33983560, 34039411, 34039412, 34043601, 34039414, 33928392, 33968957, 33968956, 33968955, 33968954, 34004876, 34043599, 34044807, 34004928, 34004927, 33968971, 34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725;
b) Domestic Serial Numbers: 33884879, 33884872, 33884912, 33884871, 33884867, 33884866, 33829105, 33829090, 33950589, 33911492, 33946302, 33884898, 33951494, 33980272, 33986554, 33818744, 33818718, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33900980, 33980275, 33980280, 33980287, 33980281, 33819680, 33829407, 33971829, 33986933, 33967385, 34011822, 34011819, 33894426, 33894572, 33900981, 33936889, 33884924, 33826068, 33981789, 33981799, 33981792, 33981805, 33981794, 33981796, 33981793, 33981795, 33981797, 33959538, 33938363, 34011821, 33894425, 33959550, 33938924, 33938921, 33922299, 33930122, 33933904, 33826017, 33955760, 33897337, 33955747, 33951295, 33951456, 33976455, 33951447, 33951275, 33979473, 33979470, 33979471, 33979472, 33979474, 33979469, 33976420, 33976429, 33976413, 33976414, 33976415, 33976416, 33976411, 33976418, 33976410, 33976424, 33976426, 33976427, 33976417, 33976412, 33976430, 33976406, 33976407, 33976408, 33976428, 33976431, 33976419, 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33929539, 33929538, 33929536, 33929535, 33930019, 33930031, 33930101, 33930042, 33930041, 33930040, 33930039, 33930038, 33930036, 33930034, 33894420, 33894573, 33894577, 33823351, 33881444, 33826061, 33826059, 33826057, 33819678, 33819663, 33818713, 33818717, 33818724, 33818728, 33818730, 33818734, 33911444, 33955786, 33981788, 33938927, 33950571, 33911630, 33904879, 33951416, 33951281, 33951274, 33911629, 33917451, 33997568, 33915923, 33915924, 33922355, 33915963, 33955849, 33921044, 33955749, 33992550, 33992554, 33959560, 33959561, 33959568, 33959562, 34052683, 34052645, 34052646, 34052647, 34052649, 34052652, 34052656, 34052657, 34052665, 34052671, 34052672, 34052675, 34052676, 34060188, 34054500, 34060186, 34060185, 34054534, 34054532, 34052677, 34054510, 34052679, 34054494, 34054492, 34052695, 34052692, 34052684, 34052641, 34054512, 33992561, 34052643, 33992567, 33992566, 33992565, 33992564, 33992571, 33992562, 33992572, 33992560, 33992559, 33992558, 33992557, 33992556, 33992555, 33992563, 33992553, 34060189, 34052639, 34052638, 34052637, 34052635, 33992568, 34022199, 34052642, 34022197, 34022196, 34022194, 34022193, 34022191, 34022190, 34022200, 34060187, 33992552, 33955782, 33951459, 33955779, 33955780, 33955781, 34060216, 34060193, 34060190, 33955785, 33986865, 33992549, 33992547, 33992545, 33992542, 33955784, 33955789, 33992540, 34060200, 34060196, 34060195, 34060194, 33955787, 34060209, 33955796, 33955790, 33955791, 33955793, 33981809, 34060201, 33955795, 34060205, 34060824, 34060819, 34060215, 34060214, 34060210, 33955788, 33981808, 33959573, 33959574, 33955805, 33959602, 33959603, 33955804, 33955801, 34060820, 33955830, 33959572, 33959609, 33955800, 33955798, 33938928, 33955853, 33955847, 33955846, 33894287, 33938359, 33938357, 33938356, 33955770, 33955756, 33955778, 33951441, 33894574, 33904918, 33904915, 33904877, 33905454, 33900863, 33901123, 33901772, 33901776, 33901783, 33901784, 33901788, 33901786, 33901760, 33901740, 33900860, 33898456, 33898453, 33946288, 33946285, 34052666, 33950581, 33819651, 33894593, 33894584, 33897332, 33951507, 33897352, 33897354, 33951443, 33951286, 33951290, 33980265, 33980307, 33981766, 33981767, 33981769, 33823355, 33997576, 33947868, 33930112, 33936855, 33936883, 33936881, 33936880, 33936856, 33936853, 33936851, 33933930, 33936898, 33936884, 33936885, 33936897, 33936895, 33936891, 33936888, 33936903, 33930118, 33933896, 33933924, 33933901, 33936904, 33986912, 34011818, 33986341, 33976461, 33959569, 33947937, 33951124, 33967369, 33967368, 33967361, 33967358, 33967354, 33967380, 33971927, 33971922, 33971944, 33971942, 33967389, 33967386, 33901118, 33901101, 33901097, 33955845, 33894412, 33911590, 33894590, 33898503, 33894578, 33894589, 33980277, 33951584, 33823377, 33936861, 33936859, 33936886, 33936892, 33936907, 33884885, 33884889, 33829091, 33829095, 33818755, 33955799, 33955835, 33946300, 33946321, 33947896, 33947921, 33936909, 33936912, 33829088, 33922371, 33971945, 33976465, 33976460, 33976457, 33976452, 33976459, 33976448, 33976450, 33976445, 31305464, 30553849, 33955844, 33955837, 33955836, 33955817, 33955851, 33959542, 33922296, 33955773, 30553852, 34015706, 33894401, 31421058, 33947912, 33980289, 33933900;
International Serial Numbers: 33947246, 33947247, 33890408, 33892605, 33790557, 33819595, 33819594, 33894427, 33826015, 33823319, 33823313, 33946278, 33933874, 33946270, 33933948, 33933865, 33933882, 33950568, 33933892, 33933893, 33933895, 33933887, 33933912, 33933913, 33933898, 33933889, 33930119, 33933884, 33826079, 33819604, 33905620, 33823314, 33946287, 33889422, 33892602, 33884927, 33884920, 33884935, 33894575, 33894408, 33894407, 33894595, 33894576, 33905610, 33905613, 33911432, 33905605, 33950445, 33915942, 33915932, 33922354, 33915948, 33915934, 33819610, 33823315, 33946291, 33946292, 33946294, 33946295, 33976467, 33946290, 33881436, 33986796, 33986798, 33986801, 33959551, 33959548, 33976462, 33959557, 33979559, 33986803, 33976405, 33976466, 33980269, 33955843, 33986812, 33986813, 33955783, 33980292, 33976473, 33976469, 33986875, 33976438, 33976439, 33986805, 33946309, 33976442, 33986806, 33976444, 33976484, 33980284, 33976449, 33986810, 33890389, 33890402, 33890398, 33890397, 33890396, 33889497, 33890390, 33889504, 33890395, 33881434, 33890417, 33890403, 33890404, 33890409, 33890407, 33890406, 33889418, 33889432, 33889431, 33889426, 33889420, 33889472, 33889417, 33889415, 33889414, 33885001, 33884998, 33884994, 33884989, 33889421, 33889481, 33889475, 34003588, 34003564, 33992548, 33986914, 34011707, 34011704, 34003590, 34003621, 34003619, 34003611, 34003605, 34003594, 34011697, 33892597, 33892606, 33892604, 33892600, 33892598, 33892609, 33892596, 33892592, 33892591, 33892589, 33986347, 33981801, 33892607, 33892608, 33892614, 33892613, 33892612, 33892610, 33884955, 33959604, 33881413, 33881411, 33881410, 33881408, 33881399, 33884986, 33881409, 33881438, 33881418, 33881421, 33881396, 33881383, 33881441, 33884914, 33884921, 33884919, 33884918, 33881439, 33884915, 33884932, 33884913, 33884907, 33884906, 33884905, 33884916, 33884954, 33884951, 33884949, 33884947, 33884943, 33884941, 33884939, 33884933, 33884869, 33884880, 33884956, 33884900, 33884895, 33884877, 33884893, 33884891, 33884883, 33819599, 33829408, 33819612, 33829394, 33829397, 33819585, 33819587, 33794788, 33814241, 33794789, 33894570, 33930104, 33932691, 33894422, 33930111, 33897330, 33897347, 33905504, 33897351, 33894550, 33897348, 33897345, 33897339, 33897338, 33897334, 33897349, 33826095, 33826096, 33823347, 33819584, 33826091, 33829094, 33826038, 33826044, 33826045, 33826047, 33826075, 33826051, 33905606, 33905624, 33911440, 33911519, 33911517, 33911514, 33826032, 33819583, 33818771, 33818767, 33819659, 33819647, 33819653, 33819658, 33819657, 33819630, 33819616, 33819619, 33819621, 33819623, 33819625, 33819626, 33819633, 33819637, 33829113, 33829108, 33829101, 33826024, 33826030, 33819615, 33823312, 33823316, 33823318, 33823320, 33823321, 33823327, 33933940, 33946279, 33933935, 33933936, 33922361, 33898444, 33922360, 33936913, 33936908, 33894549, 33933943, 33946284, 33898433, 33933957, 33932732, 33898443, 33936905, 33924677, 33933879, 33924668, 33929478, 33922379, 33922374, 33933875, 33924670, 33922373, 33922380, 33922381, 33924667, 33933871, 33933934, 33933951, 33946275, 33932735, 33922365, 33922366, 33933933, 33933862, 33933880, 33951127, 33950578, 33951103, 33950576, 33951122, 33955777, 33950456, 33947932, 33950447, 33950452, 33950453, 33950579, 33950455, 33950457, 33950570, 33950572, 33950573, 33950575, 33950454, 33922297, 33951271, 33947892, 33955850, 33959541, 33959543, 33915946, 33915959, 33951402, 33951401, 33971930, 33971931, 33971929, 33933908, 33971915, 33971912, 33936858, 33971958, 33971957, 33971952, 33971951, 33936900, 33930126, 33947881, 33947882, 33947885, 33947887, 33947888, 33936882, 33947878, 33951591, 33951587, 33971960, 33947889, 33947870, 33936901, 33947869, 33947879, 33947871, 33947872, 33947873, 33947874, 33936890, 33986326, 33955834, 33955811, 33976481, 33955810, 33976482, 33976480, 33955808, 33976483, 33889425, 33889434, 33881406, 33881393, 33881362, 33881372, 33881369, 33881366, 33881363, 33881375, 33881361, 33881360, 33881359, 33881358, 33881357, 33881356, 33881355, 33881364, 33881374, 33881380, 33881379, 33881376, 33884909, 33881450, 33881445, 33884886, 33884884, 33884894, 33819598, 33819606, 33819608, 33829152, 33829149, 33829154, 33829153, 33829150, 33829148, 33819592, 33829146, 33829144, 33819596, 33932689, 33894390, 33894389, 33892593, 33894571, 33894386, 33932679, 33881331, 33894388, 33881354, 33881353, 33881352, 33881351, 33881350, 33881333, 33881330, 33881329, 33881327, 33830738, 33881349, 33894385, 33894384, 33894383, 33894381, 33894291, 33904919, 33826060, 33826072, 33818791, 33818742, 33818787, 33819655, 33819643, 33819667, 33819635, 33823336, 33823324, 33823331, 33823317, 33946282, 33933937, 33898446, 33898432, 33933944, 33894554, 33898435, 33898436, 33933942, 33933869, 33932741, 33933870, 33933868, 33933876, 33933872, 33933858, 33932744, 33946269, 33933863, 33933861, 33950583, 33950446, 33950449, 33950574, 33947930, 33921056, 33921048, 33921054, 33933886, 33947883, 33947886, 33936902, 33947875, 33894596, 33980270, 33980299, 33986794, 33976425, 33955823, 33959553, 33959545, 33959544, 33979505, 33991489, 33991484, 33991483, 33991478, 33991494, 33991477, 33991499, 33890401, 33890400, 33890399, 33890405, 33889503, 33889502, 33889501, 33889500, 33889499, 33890424, 33890413, 33890422, 33890421, 33890420, 33890418, 33890416, 33890414, 33890412, 33890411, 33890410, 33889496, 33890415, 33889428, 33889498, 33889486, 33889495, 33889494, 33889493, 33889492, 33889491, 33889490, 33889489, 33889487, 33889484, 33889483, 33889480, 33889479, 33889477, 33892588, 33889488, 34003578, 34003565, 33997578, 33997575, 34003593, 33890423, 34011834, 34022211, 34015723, 34011708, 34011705, 34011703, 34011696, 34003592, 34011829, 34011813, 33892603, 33892601, 33892595, 33892594, 33892590, 33892599, 33981790, 33959608, 33959607, 33959600, 33959566, 33892611, 33881407, 33881416, 33881415, 33881414, 33881412, 33881395, 33881419, 33881405, 33881400, 33881398, 33881397, 33881428, 34022212, 33881435, 33946286, 33881433, 33881432, 33881431, 33881417, 33881429, 33881427, 33881426, 33881425, 33881424, 33881423, 33881420, 33881430, 33881370, 33881368, 33881365, 33881392, 33881391, 33881390, 33881389, 33881388, 33881387, 33881386, 33881373, 33881384, 33881382, 33881381, 33881378, 33881377, 33881385, 33884917, 33884910, 33884908, 33884942, 34022198, 33884948, 33884946, 33884931, 33884938, 33884936, 33884934, 33884902, 33884944, 33884904, 33884874, 33884870, 33881455, 33881454, 33881453, 33884878, 33881451, 33881449, 33881448, 33881447, 33881446, 33881443, 33881442, 33881452, 33884892, 33881440, 33884901, 33884899, 33884897, 33884896, 33884903, 33884890, 33884888, 33884887, 33884881, 33829395, 33819600, 33819601, 33819607, 33819597, 33819613, 33829409, 33829406, 33829405, 33829404, 33829403, 33829401, 33819609, 33829399, 33829398, 33829396, 33829128, 33829402, 33829142, 33819588, 33829132, 33829131, 33829130, 33819586, 33829143, 33829410, 33814240, 33814239, 33829393, 33829392, 33819589, 33819590, 33829147, 33819591, 33819593, 33819614, 33930108, 33930115, 33932678, 33894551, 33830737, 33830736, 33829411, 33924700, 33826093, 33826077, 33826078, 33826080, 33826082, 33826083, 33823374, 33826085, 33826086, 33826089, 33826033, 33826092, 33826073, 33826094, 33829140, 33823361, 33819605, 33819603, 33819602, 33823380, 33819676, 33826039, 33829093, 33826043, 33829089, 33826049, 33826050, 33823383, 33826074, 33826058, 33826062, 33826063, 33826064, 33826065, 33826066, 33826067, 33826070, 33826071, 33817019, 33818757, 33818756, 33818748, 33818745, 33818740, 33818737, 33818725, 33818761, 33818763, 33818790, 33818789, 33818788, 33818786, 33818785, 33818784, 33818782, 33818759, 33818780, 33818775, 33818773, 33818772, 33818770, 33818769, 33818768, 33818766, 33818764, 33818781, 33819646, 33819648, 33819649, 33819650, 33829125, 33819652, 33819654, 33819656, 33826034, 33819660, 33819661, 33829124, 33819664, 33829123, 33819666, 33829122, 33829121, 33819670, 33819671, 33819617, 33819618, 33819620, 33819622, 33819624, 33819627, 33819645, 33819629, 33819631, 33819632, 33829127, 33829126, 33819638, 33819641, 33819674, 33819628, 33829120, 33829115, 33829114, 33826002, 33829110, 33826006, 33829106, 33826011, 33823334, 33826014, 33823333, 33826016, 33829102, 33826020, 33826025, 33826026, 33829097, 33826028, 33826031, 33826012, 33819675, 33819677, 33819679, 33829118, 33829117, 33823335, 33819673, 33823322, 33823325, 33823326, 33823328, 33823329, 33823330, 33823332, 33922359, 33946280, 33946283, 33933954, 33933952, 33933953, 33900686, 33933939, 33933955, 33933938, 33894553, 33933946, 33898429, 33898431, 33898449, 33933956, 33898441, 33898442, 33933941, 33924678, 33929476, 33924669, 33929477, 33922368, 33922367, 33933867, 33922370, 33922376, 33946267, 33933947, 33922382, 33922378, 33929479, 33933860, 33946273, 33922363, 33946276, 33933949, 33933950, 33922364, 33933864, 33933866, 33951115, 33950582, 33950585, 33950586, 33951064, 33951074, 33951116, 33951117, 33951119, 33951120, 33951123, 33951125, 33951084, 33951132, 33924676, 33951126, 33922375, 33924662, 33924665, 33924666, 33924671, 33924672, 33924674, 33922295, 33924680, 33924683, 33924691, 33930141, 33930100, 33930099, 33924673, 33915933, 33932722, 33947926, 33915943, 33915957, 33915960, 33933902, 33933891, 33933897, 33933903, 33930120, 33930123, 33933883, 33933885, 33947895, 33947891, 33947906, 33947911, 33947914, 33947918, 33947928, 33938358, 33938361, 33947880, 33947876, 33894387, 33979498, 33979556, 33979520, 33976422, 33933881, 33946310, 33889471, 33881371, 33884922, 33894568, 33894588, 33894581, 33894579, 33884928, 33826076, 33915902
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters dated March 2006, firm initiated recall is ongoing.
REASON
Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
VOLUME OF PRODUCT IN COMMERCE
942 Lifepak 12 devices; 2678 Lifepak 20 devices
DISTRIBUTION
Nationwide and Internationally

PRODUCT ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America),
a) Software versions 7.2.2 rel 2, 7.2.2 rel 4A, 7.2.2 rel 5 and 7.3 Model: ART
Model Number: 3600066-00;
b) Model: ART Model Number: 3600078-00;
c) Model: ART Model Number: 3600082-00;
d) Model: ART Model Number: 3600084-00;
e) Model: ART 2000 Model Number: 3600090-00;
f) Model: EMERGE, EMERGE (Toshiba), EMERGE (Sceptre - Hitachi), EMERGE m
(Sceptre - Hitachi), PICO EMERGE (Sceptre-Hitachi), PICO EMERGEm (Sceptre –
Hitachi) Model Number: 3600099-00;
g) Model Number: PICO EMERGE (Sceptre-Hitachi) Model Number: P008060,
CODE
a) Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1012, 1013, 1014;
b) Serial numbers: 1001, 1002, 1003;
c) Serial numbers: 1002;
d) Serial numbers: 1001, 1002, 1003, 1004, 1005, 1006;
e) Serial numbers: 1001, 1002, 1003, 1004, 201005, 201006;
f) Serial numbers: 101001, 201002, 201003, 201004, 201005, 201006, 201007, 201008, 201009, 201010, 201011, 201012, 301013, 301014, 301015, 301016, 301017, 301018, 301019, 301020, 301022, 301023, 301024, 301025, 301026, 301027, 301028;
g) Serial number: 401001
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA Inc., Knoxville, TN
REASON There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.
VOLUME OF PRODUCT IN COMMERCE 57 devices
DISTRIBUTION KS, WA, CA, OH, FL, TX, and Internationally

PRODUCT SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery
CODE All SonoCalc IMT version 3.0
RECALLING FIRM/MANUFACTURER Sonosite, Inc., Bothell, WA
REASON When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Under estimates percentage of stenosis, false negative result.
VOLUME OF PRODUCT IN COMMERCE 155 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
CODE Lot 490694
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, 
Manufacturer: Smiths Medical, Hythe, UK,
REASON Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
VOLUME OF PRODUCT IN COMMERCE 5,350 units (107 cases)
DISTRIBUTION Nationwide

Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product

Boca Medical Products, Inc., of Coral Springs, Florida is initiating a recall of 3984 boxes of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case.  The product is being recalled because of possible bacterial presence of Bacillus Cereus and Staphylococcus Intermedius.  

Consumers who have Ultilet Syringe Insulin product lot 5GEXI, should stop usage and return the specific product.  Wholesalers should stop retail and return the product lot.  Send the product to Boca Medical Products Inc, 3550 NW 126 th Ave, Corals Springs, FL 33065.  Attention: Recall Contact.  For any question related to the case consumers should call 1-800-354-8460.

The recall include the following product:

Product Description – Ultilet Insulin Syringe 30g ½ cc
Lot – 5GEXI
NDC # - 08326-3002-50

Boca Medical method of distribution is through wholesalers.  This product is sold by prescription orders.  This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.

Consumers with questions including physicians and pharmacists may contact Boca Medical at 1-800-354-8460.

WEEK ENDING APRIL 22

PRODUCT Rubicor EnCapsule Breast Biopsy Device, Part Number 31358,
CODE Lot number: 06011817
RECALLING FIRM/MANUFACTURER Rubicor Medical, Inc., Redwood City, CA.
REASON Devices’ sterility may be compromised due to lack of adequate sterilization.
VOLUME OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION Nationwide

PRODUCT NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), 
CODE Lot codes: 3124050609-01, 3124050609-02, 3124050609-03, 3124050803-01, 3124050803-02, 3124050803-03, 3124050803-04, 3124050803-05, 3124050623-01, 5313050323-01, 5313050620-01, 5306050624-01, 5306050623-01, 5306050323-01, 4568050622-01, 4568050415-01, 3195050217-06, 3195050511-01, 3195050426-12, 3195050511-02, 3195050511-03, 3195050511-05, 3195050511-07, 3195050511-08, 3195050511-10, 3195050520-07, 3195050412-05, 3195050418-02, 3195050418-03, 3195050418-06, 3195050418-07, 3195050418-09, 3195050418-13, 3195050418-14, 3195050418-15, 3195050426-01, 3195050426-02, 3195050426-03, 3195050426-04, 3195050426-05, 3195050426-11, 3195050426-13, 3195050426-14, 3195050426-15, 3195050511-09, 3195050511-11, 3195050511-12, 3195050511-13, 3195050511-14, 3195050511-15, 3195050520-01, 3195050520-02, 3195050520-03, 3195050520-04, 3195050520-05, 3195050527-02, 3195050527-03, 3195050527-04, 3195050527-05, 3195050527-06, 3195050527-07, 3195050527-08, 3195050131-08, 3195050120-02, 3195050120-07, 3195050120-08, 3195050120-09, 3195050114-03, 3195050527-12, 3195050527-13, 3195050527-14, 3195050527-15, 3195050609-01, 3195050609-02, 3195050609-04, 3195050722-07, 3195050609-07, 3155050722-04, 3155050722-05, 3195050811-03, 3195050426-07, 3195050609-09, 3195050811-04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Respironics, Inc., Murrysville, PA
Manufacturer: Caradyne Ltd., Galway, Ireland, .
REASON Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
VOLUME OF PRODUCT IN COMMERCE 83 units
DISTRIBUTION Nationwide

PRODUCT
a) METRx II Tube, 14mm x 3cm stainless steel tubular retractor, Part No. 9569660,
b) METRx II Tube, 14mm x 4cm stainless steel tubular retractor, Part No. 9569661,
c) METRx II Tube, 14mm x 5cm stainless steel tubular retractor, Part No. 9569662, 
d) METRx II Tube, 14mm x 6cm stainless steel tubular retractor, Part No. 9569663, 
e) METRx II Tube, 14mm x 7cm stainless steel tubular retractor, Part No. 9569664, 
f) METRx II Tube, 14mm x 8cm stainless steel tubular retractor, Part No. 9569665, 
g) METRx II Tube, 14mm x 9cm stainless steel tubular retractor, Part No. 9569666, 
h) METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670, 
i) METRx II Tube, 16mm x 4cm stainless steel tubular retractor, Part No. 9569671, 
j) METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672, 
k) METRx II Tube, 16mm x 6cm stainless steel tubular retractor, Part No. 9569673,
l) METRx II Tube, 16mm x 7cm stainless steel tubular retractor, Part No. 9569674, 
m) METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675, 
n) METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676, 
o) METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680, 
p) METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681, 
q) METRx II Tube, 18mm x 5cm stainless steel tubular retractor, Part No. 9569682, 
r) METRx II Tube, 18mm x 6cm stainless steel tubular retractor, Part No. 9569683,
s) METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684, 
t) METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685, 
u) METRx II Tube, 18mm x 9cm stainless steel tubular retractor, Part No. 9569686, 
v) METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720, 
w) METRx II Tube, 20mm x 4cm stainless steel tubular retractor, Part No. 9569721, 
x) METRx II Tube, 20mm x 5cm stainless steel tubular retractor, Part No. 9569722, 
y) METRx II Tube, 20mm x 6cm stainless steel tubular retractor, Part No. 9569723, 
z) METRx II Tube, 20mm x 7cm stainless steel tubular retractor, Part No. 9569724, 
aa) METRx II Tube, 20mm x 8cm stainless steel tubular retractor, Part No. 9569725, 
bb) METRx II Tube, 20mm x 9cm stainless steel tubular retractor, Part No. 9569726, 
cc) METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730, 
dd) METRx II Tube, 22mm x 4cm stainless steel tubular retractor, Part No. 9569731, 
ee) METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732, 
ff) METRx II Tube, 22mm x 6cm stainless steel tubular retractor, Part No. 9569733, 
gg) METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734, 
hh) METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735, 
ii) METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736, 
CODE
a) Lot No. FA05K003;
b) Lot No. FA05K004;
c) Lot No. FA05K005;
d) Lot No. FA05K006;
e) Lot No. FA05K007;
f) Lot No. FA05K008;
g) Lot No. FA05K009;
h) Lot No. FA05K010;
i) Lot No. FA05K011;
j) Lot No. FA05K012;
k) Lot No. FA05K013;
l) Lot No. FA05K014;
m) Lot No. FA05K015;
n) Lot No. FA05K016;
o) Lot No. FA05K017;
p) Lot No. FA05K018;
q) Lot No. FA05K019;
r) Lot No. FA05K020;
s) Lot No. FA05K021;
t) Lot No. FA05K022;
u) Lot No. FA05K023;
v) Lot No. DC05L012;
w) Lot No. DC05L013;
x) Lot No. DC05L014;
y) Lot No. DC05L015;
z) Lot No. DC05L016;
aa) Lot No. DC05L017;
bb) Lot No. DC05L018;
cc) Lot No. DC05L005;
dd) Lot No. DC05L006;
ee) Lot No. DC05L007;
ff) Lot No. DC05L008;
gg) Lot No. DC05L009;
hh) Lot No. DC05L010;
ii) Lot No. DC05L011
RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, 
REASON Due to a manufacturing error, after autoclaving, the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.
VOLUME OF PRODUCT IN COMMERCE 61 devices
DISTRIBUTION IL, IN, MI, CA, Japan, and Netherlands

PRODUCT SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, 
CODE Software versions earlier than 5.2.2
RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver, CO
REASON Software upgrade to preclude lost images during mammography procedure.
VOLUME OF PRODUCT IN COMMERCE 80 units
DISTRIBUTION Nationwide

PRODUCT
a) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01,
b) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H, 
CODE
a) Serial numbers: 310383, 306002, 224839, 310129, 308039, 310558, 225444,
225541, 301020, 309066, 310003, 310135, 310284, 310141, 310142, 310490,
310466, 310475, 309002, 303070, 306090, 310712, 310023, 222652, 223588,
300220, 301490, 302089, 303086, 307009, 310495, 225722, 304072, 304086,
304093, 310007, 310116, 310286, 310332, 302219, 310138, 310136, 310444,
310557, 310718, 310336, 307093, 222772, 310439, 301394, 300216, 304094,
306045, 310131, 310170, 310391, 310354, 310461, 309058, 310115, 310165,
310392, 310485, 305062, 310211, 308057, 310161, 310440, 301381, 225289,
301094, 225603, 306078, 310421, 220798, 222078, 225301, 307059, 309004,
310010, 310125, 310373, 310418, 310643, 310130, 306075, 302023, 301969,
301979, 310012, 223481, 310424, 222826, 310698, 303085, 308022, 310347,
310031, 310034, 301809, 301818, 310148, 310231, 310566, 310788, 307063,
304045, 301835, 310013, 310508, 302109, 302135, 306011, 220223, 303059,
310433, 225560, 225725, 301347, 310313, 310376, 310459, 310639, 310792,
302036, 310284, 309034, 309009, 309013, 310127, 310128, 302114, 305010,
306015, 308031, 222653, 224598, 301517, 222982, 225438, 310242, 310295,
310330, 310393, 310510, 310672, 310638, 310493, 301885, 225384, 225396,
225400, 225463, 225565, 310486, 302285;
b) Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714,
350754, 350859, 350964, 350998, 351006, 351031, 351035, 351063, 351129,
351132, 351139, 350568, 350121, 350486, 350514, 350581, 350655, 350896,
350955, 350958, 350967, 350452, 350816, 350949, 350959, 350963, 351021,
351140, 350489, 350492, 350505, 350555, 350789, 350910, 250914, 350957,
351036, 350565, 351020, 350251, 350283, 350482, 350509, 350519, 350524,
350525, 350527, 350531, 350532, 350583, 350676, 350689, 351046, 350535,
350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294,
351069
RECALLING FIRM/MANUFACTURER Advanced Bionics Corp., Sylmar, CA
REASON Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
VOLUME OF PRODUCT IN COMMERCE 613 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis, 
CODE All units with Use Before Dates earlier than June, 2007
RECALLING FIRM/MANUFACTURER Medtronic Cardiac Surgery Technologies, Minneapolis, MN,
REASON Customers stated that the U-Clip deployment collar was either difficult to rotate or “locks up" during usage, which prevents the deployment of the U-Clips.
VOLUME OF PRODUCT IN COMMERCE 3383 units
DISTRIBUTION Nationwide, Japan, Belgium, Netherlands, Singapore, and Thailand

PRODUCT Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized, 
CODE Lot number: 5710119-175140, 5710790-180727, 5710941-181455, 5710942-181456, 5711046-181820, 5711047-18121, 5711227-183395, 5711397-185711, 5711448-186781, 5711724-190560, 5711777-191665, 5711930-194095, 5712202-197704, 5712203-197705, 5712254-198709, 5712255-198710, 5712256-198711, 5712965-220245, 5713055-221862, 5713056-221864, 5713059-221867, 5713060-221868, 5713061-221869, 5713261-225636, 5713419-227238, 5713420-227239, 5713657-230645, 5713658-230646, 5713789-235178, 5714079-239059, 5714507-246886, 5714566-247028, 5714665-252591, and 5714901-255263. Six pouches of unknown lot number hand carried to the University of Chicago as well as 12 pouches to the University of Missouri.
RECALLING FIRM/MANUFACTURER Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., St. Paul, MN,
REASON The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.
VOLUME OF PRODUCT IN COMMERCE 4,950 pouches
DISTRIBUTION Nationwide

PRODUCT GE Healthcare Navigation Pin Transmitter Catalog Number 1004070, Medical Systems Insta Trak Pin Transmitter, 
CODE Serial numbers: 82-2771-N, 822920-N, 82-2921-N, 82-3012-N, 82-3188-N, 82-3189-N, 82-3289-N, 89-2453-N, 89-2509-N, 89-2524-N, 89-2529-N, 89-2742-N, 89-2743-N, 89-3121-N, 89-3122-N, 89-3123-N, 8S-2094-N, 8S-2150-N, 8S2151-N, 8S-2177-N, 8S-2178-N, 8S-2179-N, 8S-2223-N, 8S-2224-N, 8S-2225-N, 8S-2226-N, 8S-2244-N, 8S-2261-N, 8S-2262-N, 8S-2292-N, 8S-2336-N, 8S-2337-N, 8S-2338-N, 8S-2339-N, 8S-2340-N, 8S-2341-N, 8S-2376-N, 8S-2380-N, 8S-2386-N, 8S-2390-N, 8S-2394-N, 8S-2443-N, 8S-2444-N, 8S-2445-N, 8S-2515-N, 8S-2516-N, 8S-2524-N, 8S-2549-N, 8S-2589-N, 8S-2590-N, 8S-2591-N, IT25147P, IT25169P, IT35153P, IT35184P, IT35191P, IT35197P, IT35198P, IT35207P, IT35208P, IT35209P, IT35211P, IT35214P, IT35216P, IT35221P, IT35223P, IT35225P, IT35226P, IT35228P, IT35232P, IT35234P, IT35240P, IT35242P, IT35244P, IT35245P, IT35250P, IT35255P, IT35260P, IT35262P, IT35263P, IT35267P, IT35269P, IT35272P, IT35275P, IT35280P, IT35285P, IT35287P, IT35291P, IT35292P, IT35293P, IT35294P, IT35295P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35305P, IT35312P, IT35315P, IT35316P, IT35317P, IT35323P, IT35324P, IT35327P, IT35328P, IT35330P, IT35336P, IT35339P, IT35342P, IT35344P, IT35348P, IT35361P, IT 35370P, IT35375P, IT35379P, IT35381P, IT35383P
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT
REASON Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
VOLUME OF PRODUCT IN COMMERCE 185 units
DISTRIBUTION Nationwide and Internationally

PRODUCT AxiEM EM Knee Kit, and associated workstation, Catalog number: 9732140,
CODE Lot numbers: 2005100642 and 2005100645
RECALLING FIRM/MANUFACTURER Medtronic Navigation, Inc., Louisville, CO,
REASON Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.
VOLUME OF PRODUCT IN COMMERCE 84 kits
DISTRIBUTION Nationwide, Australia, Austria, Israel, Singapore, Switzerland, and UK

PRODUCT
a) Cronex™ 10T, 14 x 17, Medical Screen Film, X-ray Film, 100 Sheet Box, Product code: LF5Ha, 
b) Curix™ Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14 x 17, 100 Sheet Box, Product code: EKQEG, 
c) Radiomat™ SG, 11 x 14, Medical Screen Film, X-ray Film, 100 Sheet Box, and 14 x 17, 100 Sheet Box, Product code: EK8JR and Product Code: EK8DG,
CODE
a) Lot number: 79340139;
b) Lot number: 79340029;
c) Lot number: 79360104
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC
Manufacturer: AGFA, Corp., Goose Creek, SC
REASON A localized fog pattern appears on the film.
VOLUME OF PRODUCT IN COMMERCE 712 stacks
DISTRIBUTION Nationwide and Canada

WEEK ENDING APRIL 29

PRODUCT ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092
CODE All lots
RECALLING FIRM/MANUFACTURER Blackstone Medical, Inc., Springfield, MA
REASON Pedicle Screw may disengage in post operative period requiring intervention.
VOLUME OF PRODUCT IN COMMERCE 24 sets
DISTRIBUTION AL, CA, CO, IL, NH, NM, TX, BMI, Diessen, Germany

PRODUCT VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy
CODE Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK
REASON Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.
VOLUME OF PRODUCT IN COMMERCE 2000 units
DISTRIBUTION Nationwide and Canada

*****RECALL EXTENSION******
PRODUCT
a) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left,
45 degrees, non-sterile; Part number 00-7712-035-01
b) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right,
45 degrees, non-sterile; Part number 00-7712-035-02
c) Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number
83-7712-035-01. Recall Z-0671-06 extended to include this product,
d) Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number
83-7712-035-02. Recall Z-0671-06 extended to include this product,
CODE
a) Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739,
60330363 and 60342788;
b) Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480,
60307612, 60333170 and 60336853;
c) Lots 08686700 and 08686500;
d) Lots 08686600 and 08686800
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN
REASON A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
VOLUME OF PRODUCT IN COMMERCE 527 units
DISTRIBUTION Nationwide and Internationally

PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2
CODE All serial numbers within the range of 1001 through 22000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Mc Gaw Park, IL
Manufacturer: Baxter Healthcare Corporation, Largo, FL
REASON The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.
VOLUME OF PRODUCT IN COMMERCE 14,977 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) STS-400 Levell® Skin Temperature Sensor with 400 Series Thermistor,
b) TTS-400J Levell® Tympanic Temperature Sensor with 400 Series Thermistor,
CODE
a) Lot number: 3141;
b) Lot number: 3080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Rockland, MA
Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, Mexico
REASON Product temperature readings may be 2ºC higher than the actual temperature.
VOLUME OF PRODUCT IN COMMERCE 20,400 devices
DISTRIBUTION Nationwide, Canada, France, Japan, Netherlands

PRODUCT Storz Documentation Cart with Articulating Arm, Model Number 9601F
CODE Serial numbers: 82861-8 84504-21 84505-10 84505-30 84987-15 82859-4 82859-5 82859-6 82859-7 82858-8 82858-9 82858-10 81553-1 85358-35 80486C-9 84505-14 82861-1 82861-2 82861-3 82861-4 82861-5 80486C-17 81553-14 81553-20 84987-17 84987-18 84987-19 84987-20 84987-21 84987-22 84987-23 84987-24 84987-34 84987-35 84504-20 84504-24 85358-9 80485-1 80485-2 81552-11 81552-10 81553-19 85358-37 80486C-1 80486C-2 84505-12 82858-4 82858-5 82858-6 82858-7 84987-6 84987-7 84987-8 84987-9 84987-10 84987-11 84504-17 84504-18 84504-19 84505-19 84505-20 84505-21 84505-16 84505-17 84505-18 85358-41 84504-28 82859-3 82859-2 80486C-3 80486C-4 80486C-5 80486C-6 84504-9 84504-10 82861-10 82861-9 81553-6 81553-7 81552-37 81552-19 81552-18 84505-27 84505-28 85358-40 82861-7 82861-6 82860-1 84987-1 84987-2 84505-7 81553-18 84987-3 84987-16 84504-26 85358-15 85358-16 85358-17 85358-18 85358-19 85358-20 85358-38 85358-39 85358-1 85358-2 85358-3 85358-4 85358-5 85358-6 80486C-8 85358-21 84505-24 84505-9 81552-14 81552-15 81552-16 80486C-14 81552-17 82860-2 82860-3 82860-4 82860-5 85358-33 85358-34 85358-48 85358-49 85358-50 84505-1 84505-2 84505-3 84505-4 85358-45 85358-46 85358-47 81552-22 81552-23 81552-24 81552-25 81552-26 81552-27 81552-28 81552-29 81552-30 81552-31 81552-32 81552-33 81552-34 81552-35 81553-8 81553-9 81552-4 81552-3 80485-7 82859-1 81553-3 81553-2 80486C-7 81553-10 81552-5 80486C-16 81552-6 80484B-16 80484B-17 80484B-18 80484B-19 80485-3 80485-4 82860-9 82858-1 80484B-6 80484B-7 80484B-8 80484B-9 80484B-10 80484B-11 80484B-12 80484B-13 80484B-14 80484B-15 84957A-1 84957A-3 84957A-5 84957A-4 84957A-7 84957A-2 84957A-6 84504-25 85358-8 85358-9 80486C-11 80486C-12 81553-13 82860-6 82860-7 82860-8 80485-8 80485-9 80485-10 84505-8 80484B-20 81553-4 81553-5 82858-3 85358-26 85358-27 85358-28 85358-29 85358-30 85358-31 85358-32 84987-5 84987-4 81553-15 81553-16 84505-15 85358-10 85358-11 85358-12 85358-13 84504-16 84505-22 84505-23 85358-42 85358-43 85358-44 84504-29 81552-13 80485-5 80485-6 84504-11 84504-12 84504-13 84504-14 84504-15 80486C-19 80486C-20 84505-13 84987-12 84987-28 84987-29 84987-30 84987-31 84987-32 84987-33 84987-3 86058-1 86058-2 86058-3 86058-4 86058-5 86058-6 86058-7 86058-8 84987-25 84987-26 84987-27 84987-13 84987-14 86058-11 86058-10 86058-9 86058-12 86058-13 86058-14 86058-15 86747-1 86747-2 86747-3 86747-4 86747-5 86747-6 86747-7 86747-8 86747-9 86747-10 86058-18 86058-17 86747-12 86747-13 86747-14 86747-15 86747-16 86747-11 86747-17 86747-18 86747-29 86747-30 86747-28 86747-21 86747-22 86747-23 86747-24 86747-20 86747-27 86747-31 86747-32 86747-33 86747-34 86747-35 86747-39 86747-38 86747-37 86747-36 86747-49 86747-50 86747-48 86747-46 86747-47 86747-43 86747-44 86747-45 86747-42 86058-2 86058-3 84987-36 84987-37 86058-1 82859-9 82859-10 84504-1 84504-3 84504-4 84504-5 84504-6 84504-7 84504-8 84504-2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Karl Storz Endoscopy America Inc, Culver City, CA
Manufacturer: Omni Corp., Livonia, MI
REASON The articulating arm on the cart, which holds the monitor, may fall off from the cart during manipulation. When it falls, it could hit the ground or fall on the people/objects that are in close proximity.
VOLUME OF PRODUCT IN COMMERCE 333 units
DISTRIBUTION Nationwide

PRODUCT
a) LigaSure Atlas Laparoscopic Vessel Sealer/Divider, Catalog Number LS1100,
b) LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider, Catalog Number LS1120,
CODE
a) Lot Numbers: Any lot number beginning with U, N2, N3, N4, or N5A through N5L247K;
b) Lot numbers: Any lot number beginning with N2, N3, N4, or N5A through N5L235K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valleylab, Boulder, CO,
Manufacturer: United States Surgical Corporation, North Haven, CT, 
REASON Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
VOLUME OF PRODUCT IN COMMERCE 247,000 domestic, 252000 internationally
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) MagNA Pure LC System. An automated, general purpose instrument for
isolation and purification of nucleic acids and assembly of PCR reactions.
Catalog numbers 12236931001 and 03670325001;
b) MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001,
c) MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number
03264793001,
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN
Manufacturer: Precision Systems, Chiba, Japan,.
REASON The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
VOLUME OF PRODUCT IN COMMERCE 251 instruments
DISTRIBUTION Nationwide

PRODUCT Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case
CODE Lot number: 5149116
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc. Waukegan, IL,
Manufacturer: Master & Frank Enterprise Co. Ltd, Kuantung, China,
REASON The product may not be sterile. The pouches were damaged during sterilization.
VOLUME OF PRODUCT IN COMMERCE 21 cases
DISTRIBUTION TX

PRODUCT
a) Rocker Switch Electrosurgical Pencil with E-Z Clean Tip, Catalog Number 0030H,
b) Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster, Catalog
Number 0035H
c) Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster,
Catalog Number 0036H
d) Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster,
Catalog Number 0037H;
e) Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster,
Catalog Number 0038H
f) Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster,
Catalog Number 0039H
g) Rocker Switch Electrosurgical Pencil with Holster, Catalog Number 3030HT,
h) Button Switch Electrosurgical Pencil with Holster, Catalog Number 3035HT,
CODE
a) Lot numbers: 51269, 51270, 51271, 51272, 51273, 60101, 60102;
b) Lot Numbers: 51413, 51414, 52024, 52025, 52026, 60005, 60113, 60114, 60115, 60302, 60358, 60365;
c) Lot number: 51739;
d) Lot numbers: 51762, 60119, 60383, 60384;
e) Lot numbers: 51030, 51951, 51952;
f) Lot numbers: 60121, 60456;
g) Lot number: 51624;
h) Lot number 51625
RECALLING FIRM/MANUFACTURER Megadyne Medical Products, Inc, Draper, UT
REASON Surgical device packaging may be damaged and may compromise sterility.
VOLUME OF PRODUCT IN COMMERCE 143,198 units
DISTRIBUTION Nationwide and Internationally

PRODUCT ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0
CODE Serial number 4037; serial numbers 4041, 4020, 4056, 4018, 4037; serial number 4064; serial number 4022; serial numbers 4016, 4015, 4008, 4043
RECALLING FIRM/MANUFACTURER Boston Scientific Target, Fremont, CA
REASON Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only).
VOLUME OF PRODUCT IN COMMERCE 23 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Oxoid Infectious Mononucleosis Test, Catalog # DR0680M, 
CODE Lot number: 382735, Exp. 2006/06/30
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc. Lenexa, KS
REASON Some units exhibit weak false-positive reactions with some negative patient serum.
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION Nationwide

PRODUCT Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: "b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well",
CODE AN1 (100 dose) Lot #022206 - 16404-100, Exp. Date: August 22, 2006, and AN5 (20 dose) Lot #022206 - 16404-20, Exp. Date: August 22, 2006
RECALLING FIRM/MANUFACTURER BEC Laboratories, Inc., Toledo, OH
REASON Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE 10 vials of 100 dose and 3 vials of 20 dose
DISTRIBUTION CA, CO, GA, IL, NE, OH, PR and TX

PRODUCT Mamoray™ HDR-C PLUS Mammography film
CODE Product Code: EMLOV, Batch 37300052
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, .
Manufacturer: AGFA Corp., Goose Creek, SC,.
REASON The film was incorrectly notched.
VOLUME OF PRODUCT IN COMMERCE 16,523 units
DISTRIBUTION Nationwide