JUNE 2007

JUNE 2007

WEEK ENDING JUNE 2

PRODUCT VITROS® Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD, CODE Lots 3151 and 3170
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY,
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom.
REASON Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
VOLUME OF PRODUCT IN COMMERCE Lot 3151: 1750 units; Lot 3170: 3316 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Endura No-React Dural Substitute 2 cm x 10 cm, Product code: ENR20210;
b) EnDura No-React Dural Substitute 4 cm X 10 cm, Product code: ENR20404,
c) EnDura No-React Dural Substitute 5 cm x 6 cm, Product code ENR20506,
d) Endura No-React Dural Substitute 6 cm x 10 cm, Product code: ENR20610,
e) EnDura No React Dural Substitute 10 cm x 12 cm; Product code: ENR21012,
f) EnDura No-React Dural Substitute 12 cm Diameter, Product code: ENR21212,
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp,
Manufacturer: Shelhigh, Inc, Union, NJ.
REASON Product is being recalled based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns.
VOLUME OF PRODUCT IN COMMERCE 12,736 units
DISTRIBUTION Nationwide

PRODUCT Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Part Numbers: 99040-01, 99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01, 80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc, Alameda, CA,
Manufacturer: Lahlouh, Burlingame, CA.
REASON If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.
VOLUME OF PRODUCT IN COMMERCE 67,601 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01,
b) ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01,
c) ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits),
07K60-25 (100 test kits) and 07K60-30 (4 x 500 test kits)
CODE
a) and b) All serial numbers;
c) Product Control/Lot # (For List #07K60-20): 42908JN00, 42964JN00 and 42905JN00;
(For List #07K60-25): 42909JN00, 42965JN00 and 42906JN00;
(For List #07K60-30): 42910JN00, 42966JN00, 42907JN00, and 42931JN00
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
VOLUME OF PRODUCT IN COMMERCE 3866 units
DISTRIBUTION Internationally

PRODUCT
a) Polyester braided and coated nonabsorbable surgical suture with double needle,
size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product overwrap label includes:
'2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable
Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm. Product box label
includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND
Green Polyester Braided Coated Nonabsorbable 36' (90cm),
b) Blue Polypropylene monofilament synthetic nonabsorbable
surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle.
Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene
Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm)
One Dozen Sterile. Side of box has an adhesive sticker label which includes:
'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER
POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable
Suture 18' (45 cm) STERILE EO. Product is also distributed under two private labels,
Webster Veterinary and Butler. Webster Veterinary Box Label includes:
'3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable
Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile
07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm)
3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO
Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only
26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'.
Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament
Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm
01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric)
NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene
Monofilament Synthetic Nonabsorbable Suture STERILE EO,
c) Polydioxanone Violet monofilament synthetic absorbable suture with
needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle.
Product is sealed inside an inner foil pouch with an outside tyvek pouch.
The outer tyvek pouch has the defective seal.
Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE.
Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament
Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm
3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm)
One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes:
'3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE
Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO.
Product is also distributed under three private labels, Webster Veterinary Box Label
includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture
Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01
Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet
Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament
Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only, CUTTING
NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric)
MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only
NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler
Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm)
029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable
Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.
Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures
VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable
Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm. Phoenix Pharmaceutical
Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET
MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable
Suture Veterinary Use Only Cutting PFS-2 3/8 19mm,
CODE
a) Lot numbers: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08;
b) CP Medical Product label is coded 8665P. Lot number J0629930-1 expiration 2011-09.
Private distributed label for Webster Veterinary is coded 07-836-4643(8665P).
Lot number J0629930-1 expiration 2011-09. Private distributed label for Butler is
coded 032002. Lot number J0629930-1 expiration 2011-09;
c) CP Medical Product label is coded M398A. Lot number 070122-03 expiration 2010-12.
Private distributed label for Webster Veterinary is coded 07-836-4288(M398A).
Lot number 070122-03 expiration 2010-12. Private distributed label for Butler is
coded 029254. Lot number 070122-03 expiration 2010-12. Private distributed label
for Phoenix Pharmaceutical is coded 0398. Lot number 070122-03 expiration 2010-12
RECALLING FIRM/MANUFACTURER C P Medical, Portland, OR,
REASON Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
VOLUME OF PRODUCT IN COMMERCE Polyester - 1,452 suture packets two lots; Polypropylene - 1,332 suture packets; Polydioxanone - 13,596 suture packets
DISTRIBUTION Nationwide

PRODUCT STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France; Item Number: 56602,
CODE
All units with the last 4 digits of the serial number under 3450. Serial numbers 5050012 6060290 6070319 6070346 6090389 6090416 6090417 6090418 6100419 7010600 7010601 7010602 7010603 7010604 7010605 7010606 7010607 7010608 7010609 7010611 7010612 7020648 7020649 7020650 7020651 7020652 7020653 7020654 7020655 7020656 7020683 7020684 7020685 7020686 7020687 7030745 7030746 7030747 7030748 7030749 7030751 7030752 7040808 7040809 7040810 7040811 7040812 7040813 7040814 7040815 7040816 7040817 7050834 7050835 7050836 7050837 7050838 7050871 7050872 7050873 7050874 7050875 7050876 7050877 7050878 7050879 7060931 7060932 7060933 7060935 7060936 7060937 7060938 7060939 7060940 7091037 7091038 7091039 7091040 7091041 7091060 7091079 7091080 7091081 7121199 7121200 7121201 7121202 7121203 8011222 8011223 8011224 8011225 8011226 8011228 8011229 8011230 8011231 8021232 8021233 8021234 8021235 8021236 8021237 8021238 8021239 8021240 8021241 8021242 8021243 8021244 8021245 8021246 8021247 8021248 8021249 8021250 8021251 8031259 8031260 8031261 8031262 8031263 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1092862 1102869 1102871 1102873 1102874 1102875 1102876 1102877 1102895 1102911 1112927 1112949 1112950 1112951 1112952 1112953 1112954 1112955 1112956 1112957 1112958 1112959 1112960 1112961 1112962 1123008 1123009 1123011 1123013 1123014 1123015 1123016 2013050 2013051 2013052 2023108 2023109 2023110 2023111 2023112 2023113 2023114 2023115 2023116 2023117 2023118 2023121 2023122 2023123 2023124 2023125 2023126 2023127 2023128 2023129 2023130 2023131 2023132 2023133 2023134 2023151 2023152 2023153 2023188 2023189 2023190 2023191 2023192 2033193 2033194 2033195 2033196 2033197 2033198 2033199 2033200 2033201 2033202 2033203 2043224 2043225 2043226 2043227 2043228 2043229 2043230 2043231 2043232 2043233 2043234 2043237 2043238 2043239 2043240 2043241 2043242 2043243 2043244 2043245 2043251 2043252 2043253 2043254 2043255 2043256 2043257 2043258 2043259 2043260 2043266 2043268 2043269 2043271 2043272 2043288 2043289 2043291 2043292 2043293 2043295 2043296 2043297 2053299 2053300 2053301 2053302 2053303 2053304 2053305 2053346 2053348 2053349 2053350 2053351 2053352 2053353 2053354 2053355 2053356 2053357 2053358 2053359 2053360 2053361 2053362 2063364 2063365 2063366 2063367 2063368 2073397 2073398 2073399 2073400 2073401 2073402 2073404 2073405 2073406 2073418 2073419 2073420 2073421 2073422 2073423 2073424 2073425 2073446 2073447 2073448 2073449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc, Parsippany, NJ,
Manufacturer: Diagnostica Stago, Franconville, France.
REASON Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
VOLUME OF PRODUCT IN COMMERCE 693 units
DISTRIBUTION Nationwide

PRODUCT BD 5mlSyringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free,
CODE Lot number: 7002604 Ref 309703
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Medical Systems, Canaan, CT.
REASON Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tp, Bulk Sterile Convenience Packs that may adversely affect tray integrity and steriity.
VOLUME OF PRODUCT IN COMMERCE 1500 units
DISTRIBUTION Nationwide

PRODUCT Definium AMX 700 Digital mobile x-ray system,
CODE 973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A
RECALLING FIRM/MANUFACTURER GE Medical Systems LLC, Waukesha, WI,
REASON When using the Tech Switch on exposures, 750ms, 100 kVp and 100 mAs the exposure terminates prematurely.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Nationwide

PRODUCT
a) BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs
with '8995' labeled on the swab wrapper,
b) BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs
with '8995' labeled on the swab wrapper,
c) BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs
with '8995' labeled on the swab wrapper,
d) BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065,
contain NP Swabs with '8995' labeled on the swab wrapper,
e) BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains
NP Swabs with '8995' labeled on the swab wrapper,
CODE
a) Kit Lot Numbers: 023378, 023411, 023433, 023616, 024021, 024384, 024479, 024480, 024622 NP Swabs Lot Number: 8995;
b) Kit Lot Numbers:024020, 024175, 024360, 024361, 024385, 024596,
024597, 024703, 024705, 024704, 024714, 024715, 024718, 024726, 025087 NP Swabs Lot Number: 8995;
c) Kit Lot Numbers: 023437, 024056, 024057, 024436, 024516, 024518, 024694,
024695, 024882, 025090, 025089 NP Swabs Lot Number: 8995;
d) Kit lot Numbers: 023357, 023566, 024629, 024631;
e) Lot number: 24162
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inverness Medical Professional Diagnostics, Scarborough, ME,
Manufacturer: Puritan Medical Products Co., LLC, Guilford, ME.
REASON Tip of the foam swab could detach from the shaft causing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE 13,934 kits, 185,150 Swabs
DISTRIBUTION Nationwide and Japan

PRODUCT BD AutoShield Pen Needle,
CODE Re-order Number: 329300
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Vascular Access S.A. de C.V., Nogales, Sonora Vexico.
REASON Complaints were received regarding needle stick injuries while administering insulin to patients. Label will be revised to provide clear direction on product usage.
VOLUME OF PRODUCT IN COMMERCE 496,200 units
DISTRIBUTION NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA

PRODUCT Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071,
CODE Lot #2610596
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN,
Manufacturer: Medtronic A/S, Skovlunde, Denmark.
REASON Medtronic pH 1.07 buffer solution lot #2610596 was mislabeled. The pink pH 1.07 buffer solution (catalog number 9012D1091) was placed in the pH 7.01 buffer solution bottle (catalog number 9012D1071).
VOLUME OF PRODUCT IN COMMERCE 238 units
DISTRIBUTION Nationwide

WEEK ENDING JUNE 9

PRODUCT LADAR6000 Excimer Laser System,
CODE All serial/lot numbers of the LADAR6000
RECALLING FIRM/MANUFACTURER Alcon Refractive Horizons, Inc., Orlando, FL,
REASON Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser.
VOLUME OF PRODUCT IN COMMERCE 102 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Ultrasite Horizon Pump IV Set. The product is shipped in cases containing
    24 sets,
b) Horizon Pump Metriset Burette Set. The product is shipped in cases
    containing 20 sets,
CODE
a) Lot numbers: 60883411 exp 9/09, 60886994 exp 9/09, 60883415 exp 9/09, 60883413 exp 9/09, 60883414 exp 9/09, 60883412 exp 9/09, 60883411 exp 9/09, 60883409 exp 9/09, 60883408 exp 9/09, 60883406 exp 9/09, 60883403 exp 9/09, 60884052 exp 9/09, 60884051 exp 9/09, 60883404 exp 9/09, 60883401 exp 8/09, 60883402 exp 8/09, 60883400 exp 8/09, 60883399 exp 8/09, 60883396 exp 8/09, 60883397 exp 8/09, 60883398 exp 8/09, 60880087 exp 8/09, 60880088 exp 8/09, 60880086 exp 8/09, 60880085 exp 8/09, 60880084 exp 8/09, 60880083 exp 8/09, 60880082 exp 8/09, 60880081 exp 8/09, 60880080 exp 8/09, 60880079 exp 8/09, 60880077 exp 8/09, 60880076 exp 8/09, 60880078 exp 8/09, 60880075 exp 8/09, 60880073 exp 8/09, 60880074 exp 8/09, 60875352 exp 7/09, 60875353 exp 7/09,60875350 exp 7/09, 60875348 exp 7/09, 60875349 exp 7/09, 60875347 exp 7/09, 60876056 exp 7/09, 60875345 exp 7/09, 60875346 exp 7/09, 60875344 exp 7/09, 60875343 exp 7/09, 60875342 exp 7/09, 60873263 exp 7/09, 60873262 exp 7/09, 60873260 exp 7/09, 60873261 exp 7/09, 60871825 exp 6/09, 60871439 exp 6/09, 60871824 exp 6/09, 60871823 exp 6/09, 60871438 exp 6/09, 60871437 exp 6/09, 60871436 exp 6/09, 60871435 exp 6/09, 60871434 exp 6/09, 60871433 exp 6/09, 60871431 exp 6/09, 60871432 exp 6/09, 60871430 exp 6/09, 60878152 exp 6/09, 60871429 exp 6/09, 60869484 exp 6/09, 60869482 exp 6/09, 60869479 exp 6/09, 60861428 exp 6/09, 60869467 exp 6/09, 60869466 exp 6/09, 60861993 exp 5/09, 60861995 exp 5/09, 60861996 exp 5/09, 00VL861992 exp 5/09, 00VL861991 exp 5/09, 00VL861990 exp 5/09, 60872855 exp 5/09, 60861985 exp 4/09, 60872856 exp 5/09, 60872854 exp 5/09, 60861989 exp 5/09 60861987 exp 5/09, 60859835 exp 5/09, 60861986 exp 5/09, 60859834 exp 5/09, 60859832 exp 5/09, 60859831 exp 5/09, 60859830 exp 5/09, 60872648 exp 5/09, 60872649 exp 5/09, 60859829 exp 5/09, 60880072 exp 8/09, 60880071 exp 8/09, 60880070 exp 8/09, 60880069 exp 7/09, 60875361 exp 7/09, 60875359 exp 7/09, 60875360 exp 7/09, 60875358 exp 7/09, 60875357 exp 7/09, 60875354 exp 7/09, 60875351 exp 7/09, 60869478 exp 6/09, 60869480 exp 6/09, 60869477 exp 6/09, 60869474 exp 6/09, 60869472 exp 6/09, 60869475 exp 6/09, 60872863 exp 6/09, 60869473 exp 6/09, 60869471 exp 6/09, 60869470 exp 6/09, 60869468 exp 6/09, 60883303 exp 9/09, 60883302 exp 9/09, 60883300 exp 9/09, 60883296 exp 9/09, 60892342 exp 9/09, 60892341 exp 9/09, 60892340 exp 8/09, 60894050 exp 8/09, 60892339 exp 8/09, 60894049 exp 8/09, 60883293 exp 8/09, 60883294 exp 8/09, 60880023 exp 8/09, 60880022 exp 8/09, 60891081 exp 8/09, 60891082 exp 8/09, 60891080 exp 8/09, 60880021 exp 8/09, 60878211 exp 8/09, 60878210 exp 8/09, 60889215 exp 8/09, 60878209 exp 8/09, 60878207 exp 8/09, 60878206 exp 8/09, 60888274 exp 7/09, 60878205 exp 7/09, 60878201 exp 7/09, 60886694 exp 7/09, 60886695 exp 7/09, 60878200 exp 7/09, 60875237 exp 7/09, 60875236 exp 7/09, 60875234 exp 7/09, 60875235 exp 7/09, 60883723 exp 7/09, 60873265 exp 7/09, 60875233 exp 7/09, 60873264 exp 7/09, 60869494 exp 6/09, 60869495 exp 6/09, 60869493 exp 6/09, 60882489 exp 6/09, 60869491 exp 6/09, 60869489 exp 6/09, 60869488 exp 6/09, 60862067 exp 6/09, 60877549 exp 6/09, 60862066 exp 6/09, 60862065 exp 6/09, 60861761 exp 6/09, 60861760 exp 6/09, 60870771 exp 6/09, 60861759 exp 6/09, 60862063 exp 6/09, 60862064 exp 6/09, 60861758 exp 6/09, and 60861757 exp 5/09;
b) Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA,
Manufacturer: B. Braun Dominican Republic, Inc., Santo Domingo, Dominican Republic.
REASON Secondary infusion backs up into primary container.
VOLUME OF PRODUCT IN COMMERCE 2,525,709 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02
    (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire).
The devices are comprised of four principal components including the
    ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX of LFX Catheter, and the AutoStream Flow Control,
b) FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02.
  The product is sold 5 per box,
c) ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box,
CODE
a) Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07,
    53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
b) Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07, 52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07;
c) Lot number 56662 exp 2/28/08
RECALLING FIRM/MANUFACTURER Kensey Nash Corp., Exton, PA,
REASON Insufficient wire sealing
VOLUME OF PRODUCT IN COMMERCE 586 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8161, 2M8161L, 2M8161R and 2M9161,
b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8163, 2M8163L, 2M8163R and 2M9163,
CODE
a) Product code 2M8161: serial numbers 11020103CC, 11111110CC, 11121206CC, 11121472CC, 12050210CC, 12050329CC, 12050352CC, 12050372CC, 12061422CC, 12070167CC, 12070270CC, 12070465CC, 12070501CC, 12070685CC, 13120094CC, 13120262CC, 13120277CC, 13120427CC, 13122516CC, 14020183CC, 1402033CC, 14020451CC, 14020460CC, 14020505CC, 14040928CC, 14050020CC, 14050108CC, 14050166CC, 14050254CC, 14050371CC, 14050408CC, 14050442CC, 14050466CC, 14050474CC, 14050486CC, 14050513CC, 14050536CC, 14050578CC, 14050721CC, 14050742CC, 14050759CC, 14050771CC, 14050795CC, 14050831CC, 14050928CC, 14051185CC, 14051698CC, 14051715CC, 14051727CC, 14051762CC, 14051897CC, 14051900CC, 14051905CC, 14051908CC, 14051939CC, 1405156CC, 14051976CC, 14052041CC, 14071664CC, 14100883CC, 14100939CC, 14100986CC, 14110773CC, 14110996CC, 15030562CC, 15030657CC, 15031217CC, 15031246CC, 15033836CC, 15033909CC; Product code 2M8161L: serial numbers 15072353CC, 15072705CC, 15072816CC, 15073149CC, 15073217CC, 15073271CC, 15073279CC, 15100010CC, 15100165CC, 15100463CC, 15100493CC, 15100542CC, 15100567CC, 15100783CC, 15100815CC, 15101177CC, 15101564CC, 15101613CC; Product code 2M8161R: serial numbers 11020119CC, 12041684CC, 12070373CC, 14050776CC; Product code 2M9161: serial numbers 16070001CP, 16070002CP, 16070003CP, 16070004CP, 16070008CP, 16070009CP, 16070010CP, 16070011CP, 16070012CP, 16070013CP, 16070014CP, 16070016CP, 16070018CP, 16070019CP, 16070020CP, 16070021CP, 16070022CP, 16070023CP, 16070024CP, 16070025CP, 16070026CP, 16070027CP, 16070028CP, 16070029CP, 16070030CP, 16070031CP, 16070032CP, 16070033CP, 16070034CP, 16070035CP, 16070036CP, 16070037CP, 16070038CP, 16070041CP, 16070042CP, 16070043CP, 16070044CP, 16070045CP, 16070046CP, 16070046CP, 16070048CP, 16070049CP, 16070050CP, 16070051CP, 16070052CP, 16070053CP, 16070054CP, 16070056CP, 16070057CP, 16070058CP, 16070059CP, 16070060CP, 16070061CP, 16070062CP, 16070063CP, 16070065CP, 16070066CP, 16070067CP, 16070068CP, 16070069CP, 16070072CP, 16070073CP, 16070074CP, 16070075CP, 16070076CP, 16070077CP, 16070078CP, 16070079CP, 16070080CP, 16070081CP, 16070082CP, 16070083CP, 16070084CP, 16070085CP, 16070086CP, 16070088CP, 16070090CP, 16070091CP, 16070092CP, 16070093CP, 16070094CP, 16070095CP, 16070096CP, 16070097CP, 16070098CP, 16070099CP, 16070101CP, 16070102CP, 16070103CP, 16070104CP, 16070105CP, 16070106CP, 16070107CP, 16070108CP, 16070109CP, 16070111CP, 16070112CP, 16070113CP, 16070114CP, 16070115CP, 16070116CP, 16070117CP, 16070118CP, 16070119CP, 16070120CP, 16070121CP, 16070122CP, 16070123CP, 16070124CP;
b) Product code 2M8163, serial numbers 11120044TC, 12040151TC, 12070377TC, 12070776TC, 12110299TC, 12120938TC, 13050711TC, 13050934TC, 13091241TC, 13091262TC, 13091268TC, 13120105TC, 13120220TC, 13120317TC, 13121457TC, 14020383TC, 14020388TC, 14020402TC, 14020432TC, 14020451TC, 14040398TC, 14040428TC, 14040446TC, 14040451TC, 14040456TC, 14040465TC, 14040476TC, 14040532TC, 14040572TC, 14040625TC, 14040640TC, 14040645TC, 14040655TC, 14060007TC, 14060074TC, 14060082TC, 14081238TC, 15010018TC, 15010096TC, 15010111TC, 15010139TC, 15010159TC, 15030030TC, 15030090TC, 15030203TC, 15040113TC, 12110708TC; Product code 2M8163L: serial numbers 15061723TC, 15070096TC, 15100041TC, 15100138TC, 15100147TC; Product code 2M8163R: serial numbers 12040182TC, 12070482TC, 12070714TC, 12110319TC, 15010074TC; Product code 2M9163: serial numbers 16050169TP, 16090073TP, 16090074TP, 16090075TP, 16090076TP, 16090077TP, 16090078TP, 16090079TP, 16090080TP, 16090081TP, 16090082TP, 16090083TP, 16090084TP, 16090085TP, 16090086TP, 16090087TP, 16090088TP, 16090089TP, 16090090TP, 16090091TP, 16090092TP, 16090093TP, 16100006TP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore.
REASON A small number of the pumps may power off with a single key press of the ON/OFF key, and the audible speaker tone at POWER ON may ring out of sequence.
VOLUME OF PRODUCT IN COMMERCE 122 pumps
DISTRIBUTION New Zealand, the Bahamas, Trinidad and Canada

PRODUCT
a) Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP,
b) Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid
    administration sets, 40000,
c) Custom 72 inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid
    administration sets,
d) Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP,
e) Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only,
CODE
a) Lot Number F524277;
b) Lot Number F28005;
c) Lot Number F534043;
d) Lot number F534339;
e) Lot number V536479
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT,
REASON Male luer in fluid administration sets may crack due to inadequate molding process
VOLUME OF PRODUCT IN COMMERCE 41,251 kits
DISTRIBUTION CA, IL, NJ, and NY

PRODUCT
a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System),
b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System),
c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
(Versatile cardiac and vascular),
CODE
a) 80140841 850060707 3016094100 3027444100 4134474100 5094744100 5135844100 5417684100 6309784100 7028804100 00171VAS01 00490VAS02 082406120016 082416130020 10091VAS01 190020RX09 201541SP1 251435I12 309672M4100
314569SJRM12 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 530888ANG206 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 719560INN41 727791INNOVA
803256SP 804594ANGIO 804764CATH3 812238UN41 813615CL10 816943SP1 817433HSW4100 843577CL2 845368RM10 904202SP1 904BSSP 915577SP1 952993INNOVA2 970247INNOVA 972335LIB 972566INNOVA3 A5605732 COR359867 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 XF0151
XF0153 XF0154 XF0155 XF0200 YV0001 YV0002 YV0004 YV0006 YV0007;
b) 3027443100 7022333100 082416030003 082416040015 082416040019 082416120007 082416120010 082416160008 082416210006 082416220008 082449120007 214590PH3100 303425CL4 405272SCL2 405840OIC3100 412623LAB2 414647CL1
415925INV1 480728LAB2 516562INNOVA8 573882UMC1 717782INNOVA31A 718470INNOVA2 816943STJIC1 816985NKCI 918494IN31A 920169007 A5162256 A5333035 CS1006VA03 FI1064VA01 M40480151 M4163030 YV0027 YV0028 YV0029
YV0034 YV0035 YV0037;
c) 83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01 082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6
516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3 83016102100795 83016242100936 83016802100516 83016802100866 83016802100916
83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510 cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI,
Manufacturer: GE Medical Systems, SCS, Buc Cedex, Wisconsin, France.
REASON Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen.
VOLUME OF PRODUCT IN COMMERCE 144 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110,
CODE Lot Numbers: 8529320, 8568190, 9371965
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA,
Manufacturer: Boston Scientific Corporation, Quincy, MA.
REASON Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
VOLUME OF PRODUCT IN COMMERCE 15 kits
DISTRIBUTION OH, MS, NM, MD, TX and Trinidad

PRODUCT Sienet MagicStore. Radiological Digital Image Communications System. Model number 7502052,
CODE Serial numbers 1843, 2635, 2394, 2638, 1920, 2689, 1556, 1968, 1793, 2099, 2632, 2601, 1966, 2055, 2618, 1983, and 2678.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens AG MED, Erlangen, Germany.
REASON System could crash and result in data loss.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION CA, CO, FL, MS, NH, NJ, NY, and WA

Abbott Laboratories Inc. ARCHITECT® STAT Troponin-I Immunoassay

Product: Abbott ARCHITECT® STAT Troponin-I Immunoassay,
(List #2K41, all lots).

Use: Doctors use this test in diagnosing damage to the heart and/or a heart attack (myocardial infarction) in people who have had chest pain.

Recalling Firm:

Abbott Laboratories Inc.
Firm: 100 Abbott Park Road
Abbott Park, IL 60064

Manufacturing Firm:

Thermo Fisher Diagnostics
8365 Valley Pike
P.O. Box 307
Middletown, VA 22645

Reason for Recall: A small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-I (i.e., less then 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. A falsely low troponin result may cause a doctor to send a patient home with heart muscle damage or early signs of a severe heat attack which may lead to worsening of the patient’s condition, delay in treatment and potentially death. A falsely high troponin result may lead to unnecessary surgery, which carries its own risks of harm to patients.

Patients should contact their doctor if they have any concerns about their troponin-I test results.

Public Contact: Clinical laboratories can call Abbott Customer Support at 1-877-422-2688.

For more information about this recall, visit:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/linkwarning/linkwarning.cfm?link=http%3A//www.abbott.com/global/url/pressRelease/en_US/60.5%3A5/Press_Release_0470.htm

WEEK ENDING JUNE 16

PRODUCT Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200,
CODE
US: Lot # : 2295725; 2382836; 2355074; 2390635; 2348116; 2355074; 2374619; 2216295; 2257803;2390635; 2342166; ;2390635;2348116; 2310664; 2382836; 2257803; 2216295; 2310664; 2390635; 2247199; 2247200; 2221847; 2247200; 2295725; 2310664; 2221845; 2310664; 2216296; 2257803; 2342166; European Union & Rest-Of-World Lot #: 2374619 ; 2209708;2216295; 2247200; 2310664; 2348116; 2221845 ; 2355074; 2247200; 2310664; 2216295; 2166877; 2247199; 2209708; 2367901; 2370509; 2374619; 2216295; 2163496; 2174470; 2295725; 2370509; 2376907; 2209708; 2295725; 2310664; 2221845; 2247200; 2216291; 2390635; 2360938; 2370509; 2376907; 2310664; 2355074; 2163496; 2276405; 2370508; 2221847; 2257803; 2390635; 2257803; 2370509; 2200727;
RECALLING FIRM/MANUFACTURER EV3 Neurovascular, Irvine, CA,
REASON Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
VOLUME OF PRODUCT IN COMMERCE 2,120 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510,
CODE
Serial #s: 420L-1263, 420L-1264, 420L-1265, 420L-1266, 420L-1267, 420L-1268, 420L-1269, 420L-1270, 420L-1271, 420L-1272, 420L-1273, 420L-1275, 420L-1277, 420L-1280, 420L-1281, 420L-1282, 420L-1283, 420L-1284, 420L-1285, 420L-1286, 420L-1287, 420L-1288, 420L-1292, 420L-1293, 420L-1294, 420L-1295, 420L-1296, 420L-1298, 420L-1300, 420L-1301, 420L-1303, 420L-1304, 420L-1305, 420L-1306, 420L-1307, 420L-1308, 420L-1309, 420L-1310, 420L-1311, 420L-1312, 420L-1313, 420L-1314, 420L-1315, 420L-1316, 420L-1317, 420L-1318, 420L-1319, 420L-1320, 420L-1321, 420L-1322, 420L-1344, 420L-1345, 420L-1346, 420L-1347, 420L-1348, 420L-1349, 420L-1351, 420L-1352, 420L-1353, 420L-1354, 420L-1355, 420L-1370, 420L-1403, 420L-1404, 420L-1409, 420L-1422 and 420L-1426
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Oklahoma City, OK,
Manufacturer: Sopro, La Ciotat Cedex, France.
REASON Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.
VOLUME OF PRODUCT IN COMMERCE 67 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) CryoValve, Pulmonary Valve & Conduit; Donor number 87980,
Model Number PV00,
b) Aortic Valve & Conduit; Donor number 87980, Model Number AV00,
CODE
a) Serial number 8897314;
b) Serial number 8892143
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA,
REASON Donor tissue was released prior to information received regarding a pericardial effusion.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION AZ, and CO

PRODUCT
a)

a) Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1690 and 41690 (International):

b) Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1683:
c) Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape,
b)

a) Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1691and 41691 (International):

a) Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configurations: a) catalog No. 1692:

c) Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape;
d) Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico; The cannulas are sold as components in the following configuration: catalog No. 1693: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape,
e) Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Made in Mexico. The cannulas are sold as components in the following configuration: catalog No. 1694: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape;
CODE
a) a) Lot numbers 32069/21406, 33069/22206, 34069/22606; b) lot number 33069/22206; c) lot number 33069/22106;
b) a) Lot numbers 33069/22206, 33069/22306; b) log no. 41691, lot number 32069/21406, 33069/21906; c) lot numbers 32069/21506, 32069/21606;
c) a) Lot number 35069/23405; b) lot numbers 32069/21606, 32069/21706, 33069/22306;
d) Lot numbers 32069/21406, 32069/21506;
e) Lot numbers 32069/21406, 33069/22306
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL,
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico.
REASON The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
VOLUME OF PRODUCT IN COMMERCE 13,530 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146,
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150,
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156, ;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158,
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160,
CODE
a) Lot Number: 64803;
b) Lot Number: 64603;
c) Lot Numbers: 64597, 65004, 57078;
d) Lot Number: 65015;
e) Lot Number: 66701
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis, TN,
Manufacturer: Smith & Nephew Orthopedics, Warwick, UK.
REASON The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION Europe

PRODUCT
a) Profemur® R, Revision Hip system, Proximal Body (part), X-Small model,
    REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile,
    Rx only Hip implant,
b) Profemur® R, Revision Hip system, Proximal Body (part), STD 4,
    REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile,
    Rx only. Hip implant,
CODE
a) Lot Numbers: W09356957, W09358977;
b) Lot Number: W09350601
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wright Medical Technology Inc., Arlington, TN,
Manufacturer: Wright Cremascoli Ortho SA, Toulon, France.
REASON The titanium plasma coating was found to have missing fragments.
VOLUME OF PRODUCT IN COMMERCE 22 units
DISTRIBUTION Nationwide, Puerto Rico and Japan

PRODUCT Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190),
CODE Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vision Systems Group, A Div of Viking Systems, Westborough, MA,
Manufacturer: Luxtec Corporation, A Division of LXU Healthcare I, West Boylston, MA.
REASON Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA, and NC

PRODUCT
a) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S,
b) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, 12.5' (31.8cm), sterile, REF CODE: RSG-M014S-L,
c) Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon, 15Fr (5.0mm), guidewire stylet, 12.5'(31.8cm), sterile, REF CODE: RSG-T014S-L,
d) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, handle stylet, sterile, REF CODE: RSH-L014S,
e) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S,
f) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L,
g) Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S,
h) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, handle stylet, sterile, REF CODE: RSH-T014S,
i) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflating textured balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-T014S-L,
j) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, rigid insertion stylet, sterile, REF CODE: RSR-L014S,
k) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S,
l) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm and rigid stylet, 12.5'(31.8cm), sterile, REF CODE: RSR-M014S-L,
m) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S,
CODE All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702
RECALLING FIRM/MANUFACTURER Surge Medical Solutions, LLC, Grand Rapids, MI,
REASON The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
VOLUME OF PRODUCT IN COMMERCE 2,211 units
DISTRIBUTION Nationwide and Internationally

PRODUCT FramelessArray software, Version 1.0.,
CODE Serial No’s: HZ60006 HZ60008 HZ60012 HZ60035 HZ60049 HZ60053 HZ60054 HZ60057 HZ60061 HZ60062 HZ60064 HZ60072 HZ60079 HZ60095 HZ60096 HZ60106 HZ60109 HZ60112 HZ60119 HZ60144 HZ60161 HZ60162 HZ60168 HZ60185 HZ60186 HZ60218 HZ60222 HZ60225 HZ60232 HZ60233 HZ60234 HZ60266 HZ60267 HZ60268 HZ60269 HZ60270 HZ60293 HZ60294 HZ60308 HZ60350 HZ60389 HZ60390 HZ60398 HZ60399 HZ60403 HZ60404 HZ60406 HZ60414 HZ60415 HZ60416 HZ60426 HZ60460 HZ60463 HZ60464 HZ60471 HZ60478 HZ60507 HZ60508 HZ60509 HZ60513 HZ60532 HZ60533 HZ60537 HZ60540 HZ60549 HZ60557 HZ60561 HZ60564 HZ60569 HZ60577 HZ60595 HZ60612 HZ60617 HZ60620 HZ60625 HZ60626 HZ60639 HZ60640 HZ60646 HZ60649 HZ60654 HZ60656 HZ60662 HZ60667 HZ60670 HZ60674 HZ60675 HZ60681 HZ60683 HZ60684 HZ60686 HZ60698 HZ60703 HZ60713 HZ60726 HZ60731 HZ60740 HZ64006 HZ65070 HZ66006 HZ66026 HZ66041 HZ66070 HZ66077 HZ66118 HZ66175 HZ66299 HZ67029 HZ67035 HZ67066 HZ67068 HZ67079 HZ67085 HZ67118 HZ67126 HZ67131 HZ67142 HZ68004 HZ68010 HZ68017 HZ68018 HZ68026 HZ68035 HZ68043 HZ68051 HZ68055 HZ68060 HZ68066 HZ68068 HZ68069 HZ68078 HZ68079 HZ68087 HZ68095 HZ68099 HZ68118 HZ68128 HZ68134 HZ68197 HZ68264 HZ68998 HZ69001 HZ69003 HZ69004 HZ69007 HZ69013 HZ69028 HZ69036 HZ69043 HZ69045 HZ69046 HZ69068 HZ69072 HZ69077 HZ69085 HZ69088 HZ69096 HZ69098 HZ69109 HZ69118 HZ69120 HZ69121 HZ69126 HZ69131 HZ69134 HZ69155 HZ69158 HZ69170 HZ69171 HZ69172 HZ69175 HZ69186 HZ69190 HZ69201 HZ69223 HZ69330 HZ60495 HZ60586
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA,
Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA.
REASON Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments.
VOLUME OF PRODUCT IN COMMERCE 178 units
DISTRIBUTION Nationwide and Internationally

PRODUCT c.cam Gamma Camera, Model 9VIR1200; Made in Denmark,
CODE Model 9VIR1200, serial numbers 1001 thru 1243, 1245 thru 1263, 1265 thru 1283, 1285 thru 1303, 1305 thru 1316, 1320, 1321, 1322, 1323, 1325 thru 1343, 1345 thru 1363, 1365 thru 1383, 1385 thru 1403, 1405 thru 1422, 1507, 1508, 1509.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL,
Manufacturer: Danish Diagnostic Dev. A/S, Horsholm, Denmark.
REASON Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.
VOLUME OF PRODUCT IN COMMERCE 413 cameras
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
    (Versatile cardiac and vascular imaging system.),
b) GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging System
    ( Cardiovascular Imaging System),
c) GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System), Recall # Z-0915-2007
CODE
a) 65049321 2035762100 4436432100 0002600531A 0002628342A 208227CATH1 208367INNOVA 212305CATH1 215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3 262255INNOVA2 303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1    317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 360456XCL4 405604D2100 408559INV1 410337INNOVA6 414447CA1 414649INNOVA2 417347FCV4 501257VALAB1 508856IN21 516562INNOVA6 516562INNOVA7 518243LAB1 518243LAB2 541732CV2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 610776INNOVA21 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 713375U2100 713375UCA 713794LAB1 717217CA10002 717217INN21 717544GECATH2 717544GECATH3 718470EP 727869CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN3 785354HRTEP 804764CATH2 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 815741CA1000 817329BG2100 843724CL1 843724CL2 843724CL3 845365V13 845368CATH1 858554INNOVA2   901765EP 910343EP1 910343EP2 910671CICR 910671INOV21 954987CCL7 954987CCL8 970350CL2 973579LAB1 985898INNOVAB BGRPWSCA01 CM2100 00060VAS02 00159VAS04 00192VAS04 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 35021VAS02 468668XR01 58010VAS01    600042VA03 A004RX01 A4166952 A5125125 A5164510 A5624112 A5807919 B1650215 C5123625 C5123626 DK1066VA02 DZ1006VA01 H17654VAS8 H2077VAS27 HC4355XR06    HU1094VA01 M1334109 M2068110 M2569315 M2844529 M4198195 M4200108 M4211066 MA1004VA02 NO1009VA03 PC0052XR07 PC0052XR08 SA1011VA01 SA1054VA02 SY 1001VA02 cee15663 416480INNOVA 604682INNOVA2 835160018 850060723 910162009 910162010 910162011 910162012 910163011 83016862101656 082416030004 082416040011 082416040012 082416070006 082416100012 082416120008 082416120009 082416130016   082416130019 082416130024 082416200004 082416220010 83016002101586 83016102100795 83016202101036 83016242100936 83016802100516 83016802100866 83016802100916
83016862101656 83016862101916 920169006 YV0054 YV0055 YV0056 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0070 YV0071 YV0072 YV0073 YV0077 YV0080 YX1483;
b) 65049331 2035763100 3027443100 5033703100 6106483100 6619483100 7022333100 7028533100 8014793100 8157413100 9734293100 201996LAB1 207351YCL1 207662CL4 208227CATH2 214590PH3100 219326IN31 239513CRLAB1 239939CLA 251633PROV 281420LAB23100 303425CL4 305364P3100 316651INNOVA31 352333CATH1 352333CATH2 361857CATH1 361980INNOVA2 405272SCL2 406543IN3 413582C3100 414649CL3 414649CL4 415925INV1 423844CCL1 479441SP3100 480728LAB2 480821IN2 502587LAB1 508856IN2 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573632CRC2 573882UMC1 610447CL1 610595CL1 610891CL1 616392INNOVA 617732IN9 618241GSI3100 708WESTSUB3100 717782INNOVA31A 718470INNOVA2 760242CATH1 775982CATH2 781340IN2 812450CATH1 812858GWLAB1 812858GWLAB2 814676C1 816478MC1 816943STJIC1 816985NKCI 847362CONCATH4 864255SFCL3 865481CCL2 870864LAB2    901516R3 903UT3100 904276CTH1 907562CATH1 909464IN3 909825VAINNOVA 913345MI1 916781INNOVA1 916781INNOVA1 918494IN31A 940626DCH3100 954987CCL9 970350CL1 970945CL1 405604D3100 405840OIC3100 412623LAB2 414647CL1   541MWHINNOVA 617789IN1 671GMHAINVA 770991CL1 41018VAS01 600098VA01 A5112597 A5125119 A5127281 A5162256 A5333035 B5274834 CS1006VA03 DPM32143 FI1064VA01 FPG86403 FPG93008 GE1005VA01 JO1000VA01 M4016034 M40480151 M4163030 M5480755 NO1005VA05 RU1142VA01 SA1010VA02 dpn88402 850060724 910064007 910162006 910163006 910163009 910163012 910163015 082416010006 082416020004 082416030003 082416040015 082416040018 082416040019 082416080001 082416100006 082416100013 082416110002 082416120007 082416120010 082416130015 082416130017 082416140002 082416150001 082416160003 082416160008 082416160009 082416190001 082416190003 082416190004 082416210003 082416210004 082416210006 082416210008 082416220008 082416220009 082416270002 082416300001 082416310003 082416310006 082449120007 0910064009X 834160003 910064008 920169007 YV0034 YV0043 YV0045 YV0046 YV0047;
c) 5135844100 5136864100 314569SJRM12 530888ANG206 713375U4100 804320CATH2B 804764CATH3 812238UN41 812238UN41 813615CL10 843577CL2 972566INNOVA3 80140841 3016094100 3027444100 4134474100 5033704100 5094744100 5417684100 6309784100 7028804100 201541SP1 251435I12 252847PRS3 309672M4100 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 509482HFI 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 678EJCIR1 719560INN41 727791INNOVA 770535N4100 803256SP 804594ANGIO 816943SP1    817433HSW4100 845368RM10 904202SP1 904BSSP 908522SP1 915577SP1 918682IN41 952993INNOVA2 970247INNOVA 972335LIB COR359867 00171VAS01 00490VAS02 10091VAS01 190020RX09 600152VA01 A5605732 BRD0411 IE1100VA01 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 850060707 850060722 082406120016 082416130020 XF0154 XF0155 XF0200 306766INNOVA 519663INNOVA2
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI,
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France.
REASON Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely.
VOLUME OF PRODUCT IN COMMERCE 446 units
DISTRIBUTION Nationwide and Internationally

PRODUCT AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44,
CODE 0797860, 0797861, 0797862, 0797857, 0797858, 0797859.
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL,
REASON The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION AL, Columbia and Australia

PRODUCT
a) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190,
b) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190, Recall # Z-0918-2007
CODE
a) and b) Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007;
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2007. Firm initiated recall is ongoing.
REASON Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.
VOLUME OF PRODUCT IN COMMERCE 474 units
DISTRIBUTION Australia, Canada and Germany

PRODUCT
a) Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190,
b) Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190,
CODE
a) Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007;
b) Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008 and 144208, exp. 6/30/2008
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN,
REASON Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
VOLUME OF PRODUCT IN COMMERCE 1,654 units
DISTRIBUTION Nationwide

PRODUCT LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050.,
CODE
LP 20 defibrillator serial numbers: DOMESTIC 35246397, 35222145, 35222147, 35222171, 35246407, 35195082, 35202031, 35202041, 35213722, 35213784, 35216799, 35216801, 35219423, 35219450, 35213803, 35213807, 35216785, 35216786, 35216791, 35216793, 35216797, 35219435, 35219444, 35219446, 35219447, 35219448, 35219451, 35219452, 35219463, 35219464, 35219465, 35219467, 35219469, 35222141, 35232801, 35237779, 35237782, 35237784, 35237785, 35237786, 35237788, 35237789, 35237792, 35237793, 35237794, 35237800, 35237802, 35237803, 35239818, 35222169, 35232448, 35232925, 35233140, 35195289, 35213796, 35216787, 35219445, 35216794, 35216795, 35219441, 35219457, 35219459, 35232449, 35213805, 35216784, 35216788, 35219453, 35219454, 35219461, 35150433, 35150435, 35154911, 35158493, 35158499, 35161156, 35161163, 35161242, 35161244, 35161247, 35161249, 35161251, 35161252, 35161253, 35161255, 35161257, 35161258, 35161259, 35161260, 35161262, 35161263, 35161264, 35161267, 35161268, 35161269, 35161270, 35161271, 35161272, 35161273, 35161274, 35161275, 35161276, 35161278, 35161280, 35161281, 35161282, 35161283, 35161286, 35161291, 35166342, 35166344, 35166346, 35166351, 35166354, 35166355, 35166356, 35166357, 35166359, 35166363, 35166365, 35166367, 35166371, 35166372, 35166375, 35166377, 35166381, 35166385, 35166386, 35152846, 35152854, 35150429, 35150431, 35152839, 35152862, 35154877, 35154882, 35154908, 35158482, 35226477, 35226479, 35226482, 35226483, 35226484, 35226487, 35226489, 35226492, 35226493, 35226494, 35226496, 35226498, 35226499, 35226502, 35226515, 35226516, 35233136, 35233149, 35233154, 35233153, 35152851, 35152860, 35047103, 35065639, 35065640, 35065644, 35065649, 35065652, 35065655, 35088936, 35150422, 35150424, 35151610, 35151613, 35151615, 35152861, 35154873, 35154876, 35154883, 35154888, 35152847, 35152853, 35043904, 35084040, 35088934, 35150408, 35150414, 35151616, 35152845, 35154890, 35161171, 35161261, 35161265, 35161288, 35166347, 35166352, 35166353, 35166360, 35166364, 35166366, 35166368, 35166369, 35166370, 35166373, 35166374, 35166376, 35166378, 35166379, 35166380, 35166382, 35172605, 35172611, 35172613, 35226504, 35226510, 35226481, 35233138, 35226500, 35226506, 35226519, 35226520, 35226526, 35244234, 35213806, 35219432, 35219440, 35219442, 35244337, 35226486, 35226497, 35233137, 35245167, 35226518, 35202048, 35219443, 35222137, 35219472, 35222146, 35222153, 35222168, 35219449, 35246388, 35233122, 35233144, 35232447, 35166358, 35222142, 35219456, 35239851, 35158490, 35166361, 35161254, 35226505, 35226509, 35226513, 35226521, 35226524, 35226525, 35233120, 35233123, 35233125, 35233127, 35233129, 35233131, 35233132, 35233134, 35233135, 35233139, 35233141, 35233143, 35233148, 35233150, 35233155, 35233158, 30778465, 31004425, 35233110, 35233142, 35202046, 35213791, 35219458, 35222138, 35222150, 35222156, 35222167, 35222170, 35233116, 35233145, 35233147, 35233152, 35233126, 35213732, 35216789, 35219434, 35232452, 35232810, 35233099, 35233102, 35226378, 35226508, 35233117, 35213790, 35233115, 35233151, 35213801, 35213808, 35213809, 35213810, 35216780, 35219462, 35219466, 35219468, 35219470, 35222139, 35222151, 35222157, 35222163, 35226164, 35226165, 35226166, 35226167, 35226169, 35226170, 35232443, 35232450, 35232806, 35232809, 35232910, 35232915, 35232928, 35232931, 35233090, 35233092, 35233101, 35233103, 35233104, 35233108, 35233109, 35237791, 35065654, 35233133, 35244348, 35245143, 35245162, 35245165, 35246386, 35246391, 35246394, 35246396, 35246399, 35246402, 35246416, 35246420, 35246421, 35246422, 35246423, 35246425, 35246430, 35246431, 35246432, 35246433, 35249248, 35249255, 35222140, 35226490, 35226491, 35233156, 35232442, 35232451, 35219471, 35233128, 35222148, 35222165, 35246393, 35246417, 35246426, 35249256, 35249264, 35250340, 35250349, 35250352, 35250354, 35246406, 35246408, 35187570, 35187729, 35187733, 35187740, 35187745, 35187750, 35187753, 35187754, 35192461, 35192465, 35192467, 35192474, 35192475, 35192488, 35192492, 35192494, 35195062, 35195069, 35195073, 35195074, 35195075, 35195077, 35195085, 35195086, 35195240, 35195243, 35195245, 35195246, 35195247, 35195248, 35195249, 35195250, 35195251, 35195252, 35195253, 35195254, 35195255, 35195256, 35195257, 35195258, 35195259, 35195260, 35195261, 35195262, 35195263, 35195264, 35195265, 35195266, 35195267, 35195269, 35195270, 35195271, 35195272, 35195273, 35195274, 35195276, 35195277, 35195279, 35195280, 35195282, 35195283, 35195284, 35195285, 35195286, 35195287, 35195288, 35200196, 35200197, 35200198, 35202024, 35202025, 35202026, 35202027, 35202032, 35202033, 35202042, 35202043, 35202044, 35202045, 35202047, 35202049, 35202050, 35213720, 35213723, 35213724, 35213726, 35213728, 35213730, 35213781, 35213782, 35213783, 35213785, 35213786, 35213788, 35213789, 35213792, 35213793, 35213797, 35213798, 35213799, 35213800, 35213802, 35216776, 35216777, 35216778, 35216779, 35216781, 35216790, 35216792, 35216796, 35216802, 35216803, 35216807, 35216808, 35216809, 35216811, 35216812, 35216814, 35216815, 35216816, 35219424, 35219425, 35219426, 35219427, 35219428, 35219429, 35219430, 35219431, 35219433, 35219437, 35219438, 35219439, 35232921, 35233114, 35233146, 31339155, 35222160, 35222162, 35213795, 35226480, 35226501, 35226507, 30476108, 35222166, 35232444, 35232804, 30843087, 35154880, 35244327, 35244349, 35244354, 35245145, 35245163, 35245164, 35246384, 35246385, 35246398, 35216800, 35219436, 35233098, 35233106, 35244321; INTERNATIONAL 35258119, 35258120, 35258122, 35239852, 35258124, 35222143, 35222149, 35222155, 35239835, 35239836, 35239837, 35239838, 35239855, 35239860, 35242864, 35179778, 35244352, 35246400, 35237525, 35179763, 35179769, 35179775, 35179780, 35179785, 35179786, 35179789, 35200422, 35200431, 35247341, 35252146, 35257876, 35200433, 35247343, 35244353, 35252153, 35237798, 35237799, 35237801, 35237805, 35239739, 35239741, 35239826, 35239829, 35258121, 35258123, 35257953, 35237806, 35252152, 35252709, 35256669, 35258118, 35258135, 35265693, 35222154, 35222158, 35233100, 35239839, 35237808, 35258132, 35258141, 35246419, 35257965, 35257967, 35257969, 35257972, 35257973, 35179739, 35247342, 35258125, 35258127, 35258128, 35258129, 35246389, 35246404, 35250356, 35252123, 35252129, 35239744, 35239817, 35239844, 35239845, 35242868, 35179729, 35257875, 35257874, 35258130, 35237787, 35258139, 35258140, 35237523, 35239740, 35258137, 35258142, 35265695, 35258003, 35237526, 35237810, 35239841, 35265689, 35266602, 35266603, 35252150, 35258126, 35258133, 35265687, 35265690, 35265692, 35266598, 35272212, 35272220, 35272223, 35257974, 35257975, 35239834, 35257968, 35257980, 35257987, 35252147, 35252148, 35257992, 35257995, 35258004, 35258013, 35258015, 35258016, 35258136, 35269726, 35252155, 35257832, 35258131, 35257979, 35257996, 35272213, 35272216, 35252143, 35252151, 35257993, 35257998, 35237809, 35239859, 35242858, 35258138, 35265694, 35266597, 35239843, 35257813, 35257978, 35257984, 35258002, 35257864, 35258018, 35252145, 35252154, 35257877, 35257957, 35252121, 35252135, 35252138, 35222159, 35237796, 35237804, 35237807, 35239624, 35239743, 35239820, 35239821, 35239824, 35239827, 35239850, 35242862, 35266604, 35269733, 35269751, 35270068, 35270074, 35233096, 35233097, 35232800, 35179776, 35265686, 35269723, 35269724, 35269727, 35269729, 35269730, 35269731, 35269732, 35269734, 35269735, 35269739, 35269750, 35269752, 35269754, 35270072, 35270073, 35272211, 35272214, 35272215, 35272217, 35272219, 35272221, 35272222, 35272224, 35272225, 35272226, 35272227, 35272228, 35272229, 35272230, 35272231, 35272232, 35272233, 35272234, 35272235, 35272236, 35272237, 35272238, 35272239, 35272240, 35272241, 35272242, 35272243, 35272245, 35272246, 35272247, 35272248, 35272249, 35272250, 35272251, 35272252, 35272253, 35272254, 35272255, 35272256, 35272257, 35272258, 35272259, 35272260, 35272261, 35272263, 35272264, 35272265, 35272266, 35272267, 35272268, 35272269, 35272271, 35272272, 34973329, 34975026, 35233124, 35249251, 35252113, 35252149, 35252156, 35257865, 35257866, 35257955, 35257960, 35257961, 35257962, 35257963, 35257966, 35257970, 35257976, 35257977, 35257981, 35257983, 35257986, 35257988, 35257989, 35257990, 35257997, 35257999, 35258000, 35258005, 35258006, 35258014, 35233086, 35232924, 35032726, 35274442, 35275472, 35275473, 35275475, 35027242, 35154910, 35172853, 35257856, 35213787, 35237524, 35065618, 35084010, 35179700, 35269725, 35269736, 35269746, 35269747, 35269748, 35269749, 35272244, 35272262, 35272270, 35293823, 34944167, 34975015, 35027260, 35092960, 35112569, 35113161, 35154905, 35270066, 35275476, 35275477, 35275478, 35275481, 34988041, 35239854, 35275482, 34973330, 35269722, 35272218, 34770866
RECALLING FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond, WA,
REASON White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
VOLUME OF PRODUCT IN COMMERCE 859 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100) and Item Number: 1030086, case of 1,000 (10 boxes of 100),
b) NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100) and Item Number: 1030084, case of 1,000 (10 boxes of 100),
CODE
a) M073010, M085019, M088037, M094012, M106010, M107016, M116013, M122004;
b) Lot Number: M095007, M066008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hawaii Medical LLC, Pembroke, MA,
Manufacturer: Facet Technologies Llc, Marietta, GA.
REASON Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient
VOLUME OF PRODUCT IN COMMERCE 344,434 units
DISTRIBUTION Nationwide

PRODUCT Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid,
CODE None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA,
Manufacturer: Benchmark Electronics (Thailand) PCL, Ayudhaya, Thailand.
REASON The front button covers may detach from the meter.
VOLUME OF PRODUCT IN COMMERCE Approximately 300 lots
DISTRIBUTION Nationwide and Internationally

PRODUCT Well Leg Holder with Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632,
CODE Serial #’s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK,
Manufacturer: Allen Medical Systems, Inc., Acton, MA.
REASON The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION Nationwide and Internationally

WEEK ENDING JUNE 23

PRODUCT ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent, CODE
Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL,
Manufacturer: Fisher Diagnostics, A Company of Fisher Scientific LLC, Middletown VA.
REASON False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL
VOLUME OF PRODUCT IN COMMERCE 9,438 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 83501. Product is a Collimator/ Beam Limiting Device and are replacement components for the Bucky Diagnost TH X-ray system,
CODE Part model numbers: 9896 010 00614 Accession Number 9521074 and 9511022; and 9896 010 00615 Accession Number 9521074 and 9511022
RECALLING FIRM/MANUFACTURER Philips Medical Systems North America Co. Phillips, Bothell, WA,
REASON The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard 21 CFR 1020.31 (d)(2)(iii)
VOLUME OF PRODUCT IN COMMERCE 6 collimators
DISTRIBUTION IA, LA, ND, PA, TX, and DC

PRODUCT GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor,
CODE All serial numbers of Software Version 4.1
RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee, WI
REASON Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot.
VOLUME OF PRODUCT IN COMMERCE 5,190 units
DISTRIBUTION Nationwide

PRODUCT IMS Patient Scale used on Sunrise Medical’s Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4PT-WSC and HOY- STATUREWSC,
CODE All serial numbers for Model No. HOY-4PT-WSC and HOY-STATUREWSC
RECALLING FIRM/MANUFACTURER Integrated Measurement Systems, Inc., Elk Grove Village, IL,
REASON Patient Scale may become detached, which can cause a patient to fall and result in injury.
VOLUME OF PRODUCT IN COMMERCE 149 units
DISTRIBUTION WI

PRODUCT EP Healing abutment. Product Code-ITHA52. A pre-manufactured prosthetic component directly connected to an endosseous dental implant,
CODE Lot number: 560988
RECALLING FIRM/MANUFACTURER Biomet 3i, Palm Beach Gardens, FL,
REASON Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
VOLUME OF PRODUCT IN COMMERCE 597 units
DISTRIBUTION Nationwide and Internationally

PRODUCT St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126,
CODE All devices with sterile lot numbers beginning with S, CR, or any C4 lot numbers starting with CP 05274 or higher.
RECALLING FIRM/MANUFACTURER
Recalling Firm: St Jude Medical CRMD, Sylmar, CA,
Manufacturer: Oscor, Inc., Palm Harbor, FL.
REASON Device Separation. Product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
VOLUME OF PRODUCT IN COMMERCE 14,000 units
DISTRIBUTION Nationwide

PRODUCT Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40,
CODE V036775
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN,
Manufacturer: Medtronic Puerto Rico Inc., Villalba Pr, PR.
REASON The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).
VOLUME OF PRODUCT IN COMMERCE 31 kits
DISTRIBUTION CA, CO, IL, IN, MD, NC, OH, PA, and WV

PRODUCT HUMIDIFLOW Respiratory Gas Humidifier; Part Number/Model # HMK-RM,
CODE Lot # 072849001 Serial #‘s: 1009202067, 1027061A, 100920067, 1109061, 102020061B, 102020061
RECALLING FIRM/MANUFACTURER Porous Media Corporation, Saint Paul, MN
REASON The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient).
VOLUME OF PRODUCT IN COMMERCE 178 units
DISTRIBUTION Nationwide, Canada, Mexico, and Japan

PRODUCT Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt,
CODE
Serial numbers with active patients: 79000004, 79000055, 79000064, 79000073, 79000106, 79000157, 79000181, 79000205, 79000208, 79000217, 79000226, 79000238, 79000244, 79000259, 79000274, 79000277, 79000286, 79000289, 79000298, 79000328, 79000346, 79000358, 79000364, 79000367, 79000373, 79000376, 79000379, 79000388, 79000403, 79000409, 79000445, 79000454, 79000457, 79000466, 79000487, 79000490, 79000493, 79000508, 79000511, 79000529, 79000532, 79000547, 79000556, 79000562, 79000574, 79000577, 79000595, 79000598, 79000601, 79000604, 79000616, 79000631, 79000634, 79000637, 79000640, 79000652, 79000661, 79000670, 79000686, 79000685, 79000694, 79000697, 79000715, 79000727, 79000730, 79000739, 79000754, 79000760, 79000769, 79000790, 79000796, 79000799, 79000802, 79000811, 79000823, 79000829, 79000832, 79000835, 79000838, 79000841, 79000844, 79000847, 79000853, 79000856, 79000886, 79000889, 79000901, 79000904, 79000925, 79000931, 79000934, 79000937, 79000943, 79000958, 79000973, 79000979, 79000982, 79000994, 79001003, 79001018, 79001021, 79001024, 79001027, 79001030, 79001033, 79001036, 79001042, 79001048, 79001054, 79001060, 79001066, 79001078, 79001081, 79001093, 79001099, 79001102, 79001111, 79001117, 79001147, 79001150, 79001153, 79001156, 79001162, 79001198, 79001201, 79001207, 79001216, 79001219, 79001228, 79001237, 79001243, 79001255, 79001273, 79001276, 79001288, 79001300, 79001318, 79001339, 79001354, 79001357, 79001363, 79001369, 79001372, 79001375, 79001378,79001384, 79001387, 79001399, 79001402, 79001405, 79001408, 79001417, 79001423, 79001429, 79001441, 79001444, 79001456, 79001459, 79001462, 79001468, 79001486, 79001492, 79001498, 79001501, 79001504, 79001522, 79001525, 79001528, 79001534, 79001537, 79001540, 79001558, 79001564, 79001570, 79001573, 79001582, 79001585, 79001588, 79001594, 79001597, 79001603, 79001630 79001639, 79001642, 79001648, 79001654, 79001657, 79001660, 79001666, 79001672, 79001675, 79001681, 79001690, 79001693, 79001699, 79001714, 79001717, 79001732, 79001738, 79001741, 79001744, 79001750, 79001753, 79001756, 79001759, 79001762, 79001765, 79001771, 79001777, 79001780, 79001786, 79001795, 79001798, 79001801, 79001804, 79001810, 79001822, 79001834, 79001837, 79001840, 79001846, 79001849, 79001852, 79001867, 79001879, 79001882, 79001906, 79001912, 79001918, 79001924, 79001939, 79001942, 79001945, 79001954, 79001957, 79001963, 79001969, 79001984, 79001996, 79002002, 79002005, 79002011, 79002017, 79002026, 79002041, 79002044, 79002047, 79002053, 79002056, 79002059, 79002068, 79002071, 79002074, 79002089, 79002110, 79002116, 79002119, 79002122, 79002128, 79002140, 79002152, 79002155, 79002164, 79002170, 79002176, 79002179, 79002182, 79002185, 79002191, 79002194, 79002200, 79002206, 79002215, 79002218, 79002221, 79002224, 79002227, 79002233, 79002236, 79002248, 79002251, 79002263, 79002275, 79002278, 79002287, 79002290, 79002293, 79002305, 79002308, 79002320, 79002329, 79002332, 79002338, 79002347, 79002359, 79002368, 79002377, 79002392, 79002404, 79002413, 79002416, 79002422, 79002425, 79002428, 79002440, 79002446, 79002449, 79002452, 79002455, 79002458, 79002479, 79002482, 79002494, 79002497, 79002509, 79002512, 79002521, 79002524, 79002530, 79002533, 79002539, 79002554, 79002560, 79002563, 79002566, 79002578, 79002587, 79002593, 79002602, 79002605, 79002608, 79002617, 79002620, 79002623, 79002629, 79002635, 79002644, 79002647, 79002650, 79002659, 79002665, 79002671, 79002674, 79002677, 79002698, 79002701, 79002710, 79002728, 79002740, 79002749, 79002761, 79002764, 79002767, 79002770, 79002776, 79002779, 79002782, 79002785, 79002788, 79002794, 79002800, 79002806, 79002818, 79002827, 79002833, 79002842, 79002848, 79002860, 79002863, 79002866, 79002869, 79002875, 79002878, 79002881, 79002884, 79002896, 79002899, 79002902, 79002911, 79002917, 79002932, 79002938, 79002941, 79002950, 79002962, 79002965, 79002968, 79002971, 79002974, 79002977, 79002980, 79002983, 79002989, 79002992, 79003007, 79003010, 79003016, 79003019, 79003028, 79003031, 79003034, 79003037, 79003049, 79003052, 79003055, 79003058, 79003067, 79003070, 79003079, 79003082, 79003088, 79003097, 79003103, 79003118, 79003121, 79003130, 79003133, 79003136, 79003142, 79003151, 79003157, 79003166, 79003172, 79003175, 79003178, 79003190, 79003196, 79003199, 79003205, 79003211, 79003223, 79003229, 79003235, 79003244, 79003262, 79003265, 79003274, 79003277, 79003295, 79003316, 79003325, 79003328, 79003331, 79003346, 79003349, 79003373, 79003382, 79003400, 79003415, 79003445, 79003454, 79003457, 79003460, 79003463, 79003469, 79003472, 79003478, 79003493, 79003508, 79003511, 79003520, 79003526, 79003529, 79003538, 79003544, 79003550, 79003553, 79003556, 79003568, 79003583, 79003589, 79003592, 79003598, 79003601, 79003604, 79003607, 79003613, 79003616, 79003628, 79003631, 79003634, 79003637, 79003640, 79003646, 79003649, 79003652, 79003658, 79003661, 79003664, 79003670, 79003673, 79003697, 79003700, 79003703, 79003706, 79003715, 79003718, 79003721, 79003727, 79003730, 79003748, 79003757, 79003760, 79003763, 79003766, 79003769, 79003778, 79003784, 79003793, 79003796, 79003808, 79003823, 79003835, 79003838, 79003841, 79003844, 79003847, 79003850, 79003856, 79003862, 79003868, 79003871, 79003877, 79003889, 79003916, 79003919, 79003922, 79003949, 79003958, 79003961, 79003967, 79003976, 79003985, 79003988, 79004000, 79004003, 79004012, 79004021, 79004027, 79004042, 79004066, 79004078, 79004087, 79004096, 79004108, 79004117, 79004120, 79004126, 79004129, 79004135, 79004141, 79004144, 79004153, 79004162, 79004165, 79004210, and 79004216.
Foreign serial numbers with active patients: 79000118, 79000724, 79000736, 79000343, 79000664, 79001075, 79001213, 79000310, 79000394, 79000139, 79000187, 79001231, 79001600, 79000256, 79000370, 79000463, 79000514, 79000592, 79000703, 79000745, 79000766, 79000808, 79001090, 79001171, 79001177, 79001315, 79001336, 79001345, 79001351, 79001390, 79001615, 79001825, 79001870, 79001900, 79001960, 79001966, 79002008, 79002062, 79002149, 79002203, 79002230, 79002272, 79002398, 79002464, 79002488, 79002491, 79002500, 79002545, 79002551, 79002584, 79002590, 79002611, 79002614, 79002680, 79002812, 79002953, 79003013, 79003022, 79003025, 79003094, 79003100, 79003124, 79003127, 79003139, 79003232, 79003247, 79003319, and 79003355.
Serial numbers still under the firm's control: 79000058, 79000190, 79000196, 79000211, 79000214, 79000241, 79000247, 79000253, 79000283, 79000325, 79000334, 79000340, 79000352, 79000391, 79000427, 79000439, 79000448, 79000475, 79000541, 79000544, 79000589, 79000643, 79000667, 79000712, 79000721, 79000772, 79000781, 79000784, 79000793, 79000814, 79000826, 79000850, 79000859, 79000862, 79000865, 79000874, 79000880, 79000895, 79000910, 79000913, 79000952, 79000961, 79000964, 79000985, 79000988, 79001012, 79001063, 79001072, 79001105, 79001120, 79001123, 79001138, 79001180, 79001225, 79001240, 79001252, 79001282, 79001291, 79001297, 79001303, 79001309, 79001312, 79001321, 79001324, 79001333, 79001360, 79001396, 79001420, 79001471, 79001489, 79001507, 79001546, 79001579, 79001591, 79001612, 79001621, 79001702, 79001723, 79001729, 79001792, 79001819, 79001828, 79001855, 79001861, 79001888, 79001903, 79001909, 79001927, 79001933, 79001951, 79001975, 79001981, 79001990, 79002032, 79002035, 79002038, 79002050, 79002065, 79002092, 79002095, 79002101, 79002125, 79002131, 79002134, 79002143, 79002146, 79002158, 79002173, 79002209, 79002245, 79002257, 79002269, 79002281, 79002302, 79002311, 79002314, 79002326, 79002350, 79002356, 79002395, 79002401, 79002410, 79002419, 79002434, 79002461, 79002470, 79002476, 79002569, 79002572, 79002575, 79002581, 79002596, 79002599, 79002632, 79002662, 79002683, 79002686, 79002692, 79002704, 79002713, 79002734, 79002743, 79002746, 79002773, 79002791, 79002803, 79002845, 79002851, 79002857, 79002893, 79002908, 79002923, 79002929, 79002935, 79002956, 79003019, 79003046, 79003085, 79003112, 79003148, 79003154, 79003160, 79003163, 79003169, 79003184, 79003187, 79003193, 79003214, 79003217, 79003226, 79003238, 79003241, 79003250, 79003253, 79003298, 79003301, 79003313, 79003322, 79003334, 79003340, 79003352, 79003379, 79003475, 79003481, 79003490, 79003496, 79003514, 79003541, 79003547, 79003571, 79003574, 79003577, 79003586, 79003643, 79003709, 79003724, 79003742, 79003751, 79003787, 79003790, 79003805, 79003814, 79003817, 79003832, 79003859, 79003865, 79003874, 79003892, 79003895, 79003904, 79003913, 79003925, 79003937, 79003940, 79003943, 79003952, 79003994, 79004006, 79004009, 79004030, 79004033, 79004036, 79004039, 79004045, 79004048, 79004063, 79004069, 79004072, 79004090, 79004093, 79004099, 79004102, 79004105, 79004111, 79004114, 79004132, 79004138, 79004147, 79004156, 79004159, 79004183, 79004186, 79004201, 79004204, 79004207, and 79004240.
Foreign serial numbers still under the firm's control: 79000361, 79000817, 79001132, 79001915, 79000499, 79000868, 79000898, 79001009, 79001414, 79001432, 79002284, 79003004, 79001258, 79001264, 79001279, 79001234, 79001249, 79000187, 79000559, 79001381, 79000265, 79000292, 79000349, 79000406, 79000424, 79000469, 79000520, 79000565, 79000625, 79000649, 79000673, 79000691, 79000877, 79001039, 79001087, 79001435, 79001474, 79001495, 79001513, 79001567, 79001606, 79001609, 79001774, 79001885, 79001930, 79001948, 79002020, 79002299, 79002365, 79002443, 79002503, 79002506, 79002668, 79002689, 79002755, 79002986, 32687900, 79003292, 79003310, 79003337, 79003358, 79003364, 79003403, 79003406, 79003409, and 79003412
RECALLING FIRM/MANUFACTURER Zoll Lifecor Corporation, Pittsburgh, PA,
REASON The electrodes do not properly release conductive gel
VOLUME OF PRODUCT IN COMMERCE 944 belts
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 8cm; product code/end item #000341; Single Use, Non-Sterile;
b) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 8cm; product code/end item #000342; Single Use, Non-Sterile;
c) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (5 pack); Single Use, Non-Sterile;
d) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 8cm; product code/end item #000344 and #000735 (5 pack); Single Use, Non-Sterile;
e) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 5 pack); Single Use, Non-Sterile;
f) ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 8cm; product code/end item #000380 and #000379 (5 pack); Single Use, Non-Sterile;
g) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile;
h) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; Single Use, Non-Sterile;
i) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr), length 4cm; product code/end item #000846; Single Use, Non-Sterile;
j) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile;
k) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr), length 4cm; product code/end item #000848 and #000858 (5 pack); Single Use, Non-Sterile;
l) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile;
m) ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile;
CODE Lots manufactured between May 03, 2006 and December 14, 2006. Corresponding lot numbers between 0605031 and 0612141. Lot code breakdown as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Endoscopic Technologies, Inc., Billerica, MA,
Manufacturer: Servicios Ensamble Internacionales, Ciudad Juarez, Mexico.
REASON Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
VOLUME OF PRODUCT IN COMMERCE 12,350 packaged units
DISTRIBUTION Nationwide and Internationally

PRODUCT Biomet 3i, disposable twist drills, Model number DT2715, CODE Lot Numbers: 635699—2012-1 and 652460—2012-3
RECALLING FIRM/MANUFACTURER Biomet 3i, Palm Beach Gardens, FL,
REASON The depth indicator laser line markings on the drills are too faint for clinicians to read during use.
VOLUME OF PRODUCT IN COMMERCE 147 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
b) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
c) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
d) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 21-U-V), 21mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
e) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 25-U-V), 25 mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
f) Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,(PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip,
CODE
a) 5713042-221741, 5713423-227242, 5717696-316474, 5717892-318414, 5718084-321564, 5718811-335330, 5718931-337921, 5719156-342542, 5717892-408336, 5718084-408339, 5719536-348390, 5721731-391016, 5721732-391017, 5721988-395784, 5722089-397032,
5725033-478976, 5725482-487062, 5725665-491224, 5725782-495452, 5726120-498547, 5727333-525321, 5721988-540345, 5727334-525322.
EXPANDED LOT/SERIAL #'s: 5728409-544891, 5729325-562207, 5727334-560764;
b) 5719288-345247, 5720137-358402, 5720206-359198, 5721249-375999, 5721733-391018, 5723148-421902, 5722090-397033, 5722420-406658, 5723509-433792, 5723703-439270, 5723810-441317, 5724696-467329, 5725034-478977, 5725483-487063, 5725792-495462,
5726121-498548, 5726493-506246, 5721249-540340, 5726841-516569.
EXPANDED LOT/SERIAL #'s: 5726841-560767, 5726842-516570, 5727664-532483, 5727970-538817, 5727971-538818, 5728410-544892, 5728683-549953, 5729326-562208,
5729700-569547, 5729701-569548;
c) 5713060-221868, 5713061-221869, 5714567-250264, 5712862-215844, 5715407-268139, 5717353-310944-001, 5717354-310947-002, 5717355-310948-003, 5717356-310950-004,
5717357-310951-005, 5717358-310953-006, 5717359-310954-007, 5717360-310955-008, 5717361-310956-009, 5717362-310957-010, 5717403-311742-017, 5717404-311743-018, 5717405-311744-019 , 5717406-311745-020, 5717407-311746-021, 5717408-311747-022,
5717409-311748-023, 5717410-311749-024, 5717411-311750-025, 5717412-311751-026, 5717413-311752-027, 5717414-311753-028, 5717415-311754-029, 5717416-311755-030, 5717397-311734-011, 5717398-311737-012, 5717399-311738-013, 5717400-311739-014,
5717401-311740-015, 5717402-311741-016, 5717417-311756-031, 5717418-311757-032, 5717578-314896-033, 5717579-314897-034, 5716064-280283, 5716065-280284, 5717580-314898-035, 5717581-314999-036, 5717582-314901-037, 5717583-314902-038,
5717584-314903-039, 5717585-314904-040, 5717586-314905-041, 5717587-314906-042, 5717588-314907-043, 5717589-314908-044, 5713061-396028, 5713061-396088, 5714567-395788, 5714567-396037, 5714567-396041, 5714567-396047, 5714567-396085, 5714567-396831, 5714567-408289, 5716453-285027.
EXPANDED LOT/SERIAL #'s: 5716453-285027, 5716453-577195;
d) 5713057-221865, 5713421-227240, 5727945-538783, 5728518-547271.

EXPANDED SERIAL/LOT #'s: 5728518-560761 and 5729324-562206;
e) 5713058-221866, 5713424-227243, 5718660-334090, 5719772-353003, 5721250-376000;
f) 5713059-221867, 5713425-227244, 5717618-314939-001, 5717619-314940-002, 5717620-314941-003, 5717621-314942-004, 5717622-314943-005, 5717623-314944-006,
5717624-314945-007, 5717625-314946-008, 5717626-314947-009, 5717627-314948-010, 5713059-301281, 5713425-332644, 5713425-332648, 5713425-395826.
EXPANDED SERIAL/LOT#: 5716063-280282
RECALLING FIRM/MANUFACTURER Synovis Surgical Inovation, Saint Paul, MN
REASON Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
VOLUME OF PRODUCT IN COMMERCE 3,902 units
DISTRIBUTION Nationwide

WEEK ENDING JUNE 30

PRODUCT
a) LIFEPAK CR Plus defibrillator,
b) LIFEPAK EXPRESS defibrillator,
CODE
a) Serial Numbers are for units with lead free capacitor C177. The following list of Serial Numbers does not include units sent to Japan, as firm does not consider them to be part of the Safety Alert action. Serial Numbers: 34229586, 33954394, 34062775, 34327707, 34032903, 34032904, 34032905, 34032906, 34032907, 34032908, 34033024, 34033025, 34221247, 34221248, 34221249, 34221250, 34237877, 34237878, 34303970, 34234668, 34234669, 34234670, 34234671, 34234672, 34234673, 34234675, 34234676, 34308771, 34070269, 34070270, 34070271, 34070272, 34037665, 34037666, 34037667, 34236080, 34017406, 34211855, 34193023, 33955732, 34257894, 34037623, 34037624, 34054882, 34041445, 34041446, 34041447, 34041449, 34041450, 34041451, 34041452, 34041453, 34041454, 34041456, 34041462, 34041470, 34041477, 34041478, 34041524, 34041526, 33950879, 34174883, 34174884, 34037386, 34051164, 33954390, 34330008, 34056748, 34056711, 34019336, 34019337, 34054905, 34050294, 34050295, 34050296, 34515434, 34056695, 34056698, 34056741, 34056720, 34056765, 34037672, 34056743, 34211858, 34715875, 34212825, 34212829, 34062574, 34056750, 34056860, 34206201, 34236064, 34022638, 34326942, 34326944, 34326945, 34326946, 34326948, 34326949, 34326951, 34326952, 34326953, 34326955, 34326956, 34326957, 34326961, 34326965, 34331505, 34333037, 34333038, 34333039, 34333040, 34333041, 34333042, 34333043, 34333045, 34333272, 34333273, 34333274, 34333276, 34333278, 34716686, 34237880, 34062770, 34229643, 34206206, 34036781, 34345451, 34229616, 34227945, 33932374, 34124932, 34206203, 34050681, 34257909, 34034576, 34345456, 34331265, 34296099, 33925248, 34250001, 34059634, 34057967, 33972950, 33972952, 33972954, 33972949, 33972953, 34302353, 33972947, 33972948, 34013903, 34251777, 34229640, 34042101, 34042102, 34042103, 34042104, 34042105, 34042106, 34234683, 34274164, 33972951, 34026455, 34034588, 34300518, 34219424, 34300540, 34330067, 34300777, 34206181, 34206169, 34297030, 34206167, 34331262, 34206175, 34206176, 34206178, 34206179, 33931303, 33931302, 34053408, 34053409, 34046839, 34236049, 34236052, 34335111, 34335112, 34230327, 34236001, 34717346, 34230323, 34230324, 34046854, 34211861, 34026302, 34330255, 34333019, 34236036, 34236094, 34022647, 34235985, 34211851, 34211852, 34211853, 34006672, 34006536, 34006488, 34006497, 34049992, 34037721, 33972848, 33972844, 33972845, 33930848, 34298525, 34298526, 34044691, 34070202, 34211866, 34211867, 34211868, 34211869, 34229646, 34229647, 34246314, 34246315, 34246316, 34246326, 34246327, 34246328, 33931434, 34323786, 34236017, 34230210, 34037374, 33953196, 33953203, 33953207, 33953211, 33953216, 34249855, 34302336, 34302344, 34306939, 34234419, 34234420, 34308685, 34327089, 34327090, 34255359, 34304531, 34304533, 34249919, 34249921, 34249922, 34249923, 34249924, 33954467, 34056759, 34216741, 33954397, 34345461, 34034570, 34062476, 34062477, 34062478, 34237867, 34237869, 34058156, 33972935, 33972936, 33972937, 33972938, 34333764, 34327209, 34327211, 34327115, 34327223, 34330298, 34062753, 34274445, 34274446, 34319629, 34037786, 34063499, 34192109, 34192110, 34192111, 34192112, 34192113, 34192114, 34192115, 34192116, 34192118, 34037384, 33954689, 34327122, 34333761, 34336240, 34019326, 34032560, 34345448, 33954174, 34216756, 34216757, 34216758, 34216759, 34216760, 34216761, 34216762, 34216763, 34216765, 34216766, 33961378, 33961379, 34039293, 34037376, 34234690, 34234691, 34042068, 34042072, 34042075, 34056768, 34056756, 34052398, 34056850, 34215351, 34215352, 34215354, 34215358, 34215359, 34050694, 34274438, 34274439, 34274441, 34206213, 34206214, 34206215, 34206216, 34206217, 34206218, 34229589, 34049886, 34049888, 34049890, 33951640, 34056922, 34329891, 34232727, 34062572, 34034592, 34240408, 34056932, 33954487, 33935886, 33935889, 34328900, 34066969, 34036004, 34036005, 33997805, 33997807, 34163376, 34240402, 34240403, 34240404, 34261953, 34304067, 34304073, 34304071, 34281310, 34328941, 34328942, 34059636, 34234687, 34057905, 34158795, 34034773, 34056935, 34330602, 34060497, 34234685, 33950884, 34011980, 34274169, 34328812, 34042242, 34274451, 34274453, 34274454, 34304057, 34304058, 34022644, 34037789, 34037790, 34050763, 33956060, 34053023, 34053024, 34053025, 34212830, 34212832, 34088058, 33954774, 33954779, 33954781, 33954783, 33954788, 34335634, 34060218, 34033111, 34304537, 34243861, 34044717, 34044719, 34044720, 34044721, 34304535, 34304540, 34274167, 34004537, 34004541, 34004543, 34004544, 34060192, 34212897, 34212900, 34333327, 34229662, 34208365, 34008765, 34012012, 33951455, 33951648, 34208357, 34008763, 34208360, 34092654, 34092655, 34092656, 34236106, 34274457, 34249857, 34333236, 34340022, 34092706, 34092709, 34058003, 34250124, 34250125, 34206220, 34012457, 34053014, 34012455, 34212869, 34571415, 34057889, 34056816, 34048366, 34048367, 34048368, 34048370, 34026377, 34208338, 34208340, 34345463, 34454192, 34206184, 34336346, 34206222, 34454294, 34229650, 33953951, 34336358, 34049803, 34006039, 34006040, 34032454, 34356554, 34006698, 34006704, 34006705, 34006706, 34006712, 34006713, 34006714, 34006715, 34304579, 34268929, 34268930, 34268931, 34268932, 34268933, 34268948, 34268949, 34268954, 34268956, 34268971, 34268972, 34268973, 34268981, 34268983, 34268984, 34268985, 34268991, 34268993, 34274526, 34274175, 34011796, 34011781, 34004561, 34331257, 34331258, 34057991, 34062644, 34062645, 34062646, 34398170, 34221669, 34158804, 34229665, 34243872, 34240412, 34336317, 34062692, 34193025, 34019034, 34032580, 34032585, 34032582, 34327216, 34327705, 33953018, 33953031, 33953039, 33953042, 33953049, 33953051, 33953066, 33953109, 33953110, 33953115, 33953117, 33953123, 33953132, 33953136, 33953138, 33953152, 33953158, 33953168, 33953173, 33953178, 33953183, 33953186, 33953194, 34303987, 34303988, 34013071, 34208349, 34208351, 34105929, 34058001, 34304575, 34304576, 34304577, 33973912, 34019230, 34019231, 34015565, 34015566, 34015567, 34018237, 34018239, 34018240, 34018241, 34018242, 34018243, 34018244, 34018245, 34018246, 33951400, 34008506, 34017411, 34026367, 34486152, 34327097, 33998063, 33998064, 34441601, 34441603, 34441608, 34350851, 34009136, 34009138, 34009139, 34093000, 34350849, 34298564, 34329983, 34329985, 34329986, 34329987, 34329988, 34329989, 34329990, 34329991, 34329992, 34329993, 34329994, 34329995, 34329999, 34330001, 34330846, 34009131, 34009132, 34009140, 34009146, 33973005, 34066456, 34350853, 34350845, 34050706, 33974233, 34042147, 34213210, 34380269, 34006263, 34058301, 34213821, 34213823, 34441578, 34236436, 34236402, 34274231, 34255395, 34255397, 34255398, 34255399, 34255400, 34255401, 34255402, 34255403, 34255412, 34255413, 34255414, 34255415, 34255417, 34255418, 34255420, 34255421, 34255422, 34255423, 34255424, 34255425, 34255427, 34255428, 34255429, 34255430, 34255431, 34255432, 34234713, 34234714, 34234715, 34234716, 34234719, 34234720, 34234721, 34234722, 34234723, 34234724, 34234725, 34234726, 34234727, 34234728, 34255416, 34255419, 34053017, 34042238, 34234738, 34053037, 34053038, 34053041, 34274209, 34346592, 34305812, 34255411, 34304000, 34295240, 34295241, 34002754, 34002755, 34002756, 34002757, 34002758, 34002760, 34002761, 34002762, 34002763, 34002764, 34014050, 34207104, 34006260, 33935829, 34332957, 34070133, 34058063, 34272760, 34004871, 34255396, 34334847, 34213568, 34034746, 34274233, 34330722, 34330723, 34331617, 34009591, 34398235, 34320714, 34059572, 34191980, 34191981, 34191982, 34191983, 34191985, 34191986, 34191987, 34191988, 34191990, 34191991, 34358392, 34033119, 34037793, 34244243, 34046794, 34239054, 34014030, 34207113, 34207114, 34017296, 33994864, 33994866, 33994868, 34213129, 34304059, 34051162, 34017279, 34012557, 34012558, 34012559, 34012560, 34012561, 34012562, 34012563, 34012564, 34012565, 34009141, 34002564, 34332942, 34003891, 34329783, 34329784, 34009129, 34009134, 34009142, 34331390, 34331391, 34336376, 34058176, 34058179, 34002570, 34062685, 34297509, 33998417, 34009101, 34013792, 34002563, 34274188, 34062604, 34213501, 34037465, 34002561, 34013736, 34051332, 34051335, 34017385, 34066796, 34014863, 34014864, 34014865, 34014866, 34014868, 34014869, 34014870, 34014871, 34014872, 34014873, 34014874, 34014875, 34014876, 34014877, 34014878, 34014879, 34014880, 34014881, 34014882, 34014883, 34014884, 34014886, 34014887, 34014888, 34014889, 34014890, 34014891, 34014892, 34014893, 34014894, 34014895, 34014896, 34014897, 34014898, 34014899, 34014901, 34014902, 34014903, 34014904, 34014905, 34014906, 34014907, 34014908, 34014909, 34014910, 33994769, 33994770, 33955613, 33961428, 34056387, 34056753, 34045412, 34045414, 34045418, 34045420, 34045421, 34045423, 34045426, 34045428, 34045430, 34045432, 34066397, 34066445, 34066449, 34058254, 34454097, 34210042, 34210043, 33953564, 34050708, 34050844, 34274212, 34051154, 34062784, 34062785, 33973001, 33973006, 33973010, 33973012, 34303996, 34303997, 34345524, 34345469, 34210091, 33997800, 33997801, 34333251, 34333252, 34335248, 34335236, 34333248, 34006253, 34006277, 34045415, 34045419, 34333717, 34045434, 34324283, 34022767, 34274183, 34306320, 34306325, 34306331, 34306335, 34306342, 34306348, 34306349, 34306351, 34306354, 34306355, 34274181, 34012331, 34308774, 34045427, 34066447, 34066440, 34050846, 34235016, 34066466, 34345477, 34345478, 33936167, 34298580, 34050916, 34050869, 34318028, 34066406, 33973002, 34046414, 34046427, 34046433, 34240438, 34240465, 34304061, 34093058, 34093061, 34093066, 34213538, 34215721, 34215723, 34066446, 34066450, 34032784, 34239535, 34050875, 34268532, 34268533, 34268534, 34330683, 34239058, 34239063, 34315450, 34060549, 34060550, 34051150, 34051148, 34039714, 34045435, 34050866, 34037661, 33925185, 33925186, 33925187, 33925188, 33925189, 33925190, 33925194, 33925205, 34240430, 34345507, 34345504, 34213923, 34042287, 34042288, 34042289, 34042290, 34042291, 34042292, 34042293, 34042294, 34042296, 34042297, 34042299, 34042302, 34042303, 34042304, 34042306, 34042307, 34042308, 34042309, 34042310, 34042311, 34042312, 34042314, 34042316, 34042318, 34042321, 34042322, 34042323, 34042324, 34042325, 34042326, 34042327, 34042328, 34042329, 34042330, 34042331, 34044468, 34333708, 34333709, 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