WEEK ENDING OCTOBER 14

PRODUCT  MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system,

CODE All MiniView 6800 systems

RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT,

REASON Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

VOLUME OF PRODUCT IN COMMERCE 534 units

DISTRIBUTION Nationwide

 

PRODUCT

a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system,

b) GE OEC 9800 Fluoro C-Arm X-ray system,

c) RUS Tool Version Software,

CODE

a), and b) All units;

c) All versions prior to Version 7.1.43

RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT,

REASON X-ray systems could provide output which exceeds the 20 R/minute limit.

VOLUME OF PRODUCT IN COMMERCE 11,279 units

DISTRIBUTION Nationwide and Internationally

 

PRODUCT GE Precision RX/I System, 
CODE All units

RECALLING FIRM/MANUFACTURER General Electric Med Systems, LLC, Waukesha, WI,

REASON Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv).

VOLUME OF PRODUCT IN COMMERCE 30 units

DISTRIBUTION Nationwide

 

PRODUCT Smith & Nephew Hip Positioning System Ref: 72200624 with System Components.  Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629

CODE Product distributed prior to May 5, 2006

RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc., Endoscopy Division, Andover, MA,

REASON The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION Nationwide

 

PRODUCT

a) Ammonia/alcohol Control Set for the quantitative determination of  ammonia/alcohol in blood.  Catalog number A7504-CTL,

b) Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum.  Imported and marketed in India.  Catalog number A7504-150-S,

c) Alcohol Standard, 100 mg/di, Catalog # A7504-STD,

d) Alcohol Control, Catalog # 7-A7504-CTL,

e) Alcohol Control, Level 1. Catalog # 7-A7504-CTL-L1,

f)  Alcohol Control, Level 2. Catalog # 7-A7504-CTL-L2,

g) Alcohol Standard, Catalog # 7-A7504-STD, 
CODE

a), d), e), and f)  Lot 522202, exp. 7/06;

b) Lot 507401;

c), and g) Lot 509102, exp. 9/06

RECALLING FIRM/MANUFACTURER Pointe Scientific, Inc., Canton, MI,

REASON Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.

VOLUME OF PRODUCT IN COMMERCE 699 units

DISTRIBUTION Nationwide and Internationally

 

PRODUCT GE 4 inch Anterior Cervical Post, GE Part Number: 1006385 or 1006385-NAV, (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)

CODE All lot numbers.

RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT,

REASON Weld defect – the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

VOLUME OF PRODUCT IN COMMERCE 208 units

DISTRIBUTION Nationwide and Internationally

 

PRODUCT Thoratec brand TLC-11 Portable Ventricular Assist Device (VAD) Driver,

CODE All codes

RECALLING FIRM/MANUFACTURER Thoratec Corp., Pleasanton, CA

REASON Sticky valve disk – The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.

VOLUME OF PRODUCT IN COMMERCE 57 units

DISTRIBUTION Nationwide and Internationally

 

PRODUCT

a) Stryker Navigation System, eNite System with Dell laptop computer model D800, Stryker # 7700-300-000,

b) Stryker Navigation System Remote Planning Station with Dell laptop computer model D800, Stryker # 7700-010-000,

c) Stryker Navigation System, Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064,

d) Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000,

CODE All units

RECALLING FIRM/MANUFACTURER Stryker Instruments, Division of Stryker Corporation, Portage, MI,

REASON A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

VOLUME OF PRODUCT IN COMMERCE 218 laptops

DISTRIBUTION Nationwide and Internationally

 

PRODUCT

a) Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817, 
b) Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486,

c) Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers:  71927102, 71927103, 71927104, 71927105,

CODE

a) Catalog number 74018811 Lot Numbers: 06CM3493, 06CM03494, 06CM11279, 06CM11280, 06DM01843, 06DM01844, 06EM04235, 06EM04237, 06EM07308, 06FM11461, 06FM11462, 06GM00024, 06GM00024, 06GM00025, 06GM00026, 06GM00027, 06GM00028

Catalog number 74018813 Lot Numbers: 06CM03491, 06CM03492, 06CM03492A, 06DM09155, 06DM09156, 06DM09157, 06DM09158, 06DM12567, 06DM12568, 06DM12569, 06DM12570, 06DM12571, 06EM07309, 06EM07310, 06FM02041, 06FM02042, 06FM11464,

06FM11465, 06GM06530, 06GM06531 

Catalog number 74018815 Lot Numbers 06CM03489, 06CM03490, 06CM03490A, 06CM11283, 06CM11284, 06DM01852, 06DM01853, 06DM09532, 06DM09534, 06DM09535, 06DM09536, 06FM11466, 06FM11467, 06GM00029, 06FM00030, 06GM00031, 06GM00032,

06GM06532, 06HM05954, 06HM05955, 06HM05956, 06HM05957, 06HM05958, 06HM05959

Catalog number 74018817 Lot Numbers: 06CM03486, 06CM03487, 06CM03488, 03CM03488A, 06CM12230, 06CM12231, 06DM01851, 06DM12572, 06DM12573, 06DM12574, 06DM12575, 06DM12576, 06FM11468, 06FM11469, 06GM00033, 06GM00034, 06GM00035,

06GM00036, 06GM10621;

b)  Catalog Number 71440480 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.

Catalog Numbers 71440482 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.

Catalog Number 71440484 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes.

Catalog Number 71440486 Lot Numbers: All lots prior to 06MM***** Sequence, including those items with suffixes;

c)  Catalog Number 71927102 (Size 1-2) Lot Numbers 06AM00936, 05KM07017, 04KM18886, 04JM05040, 03FM11332, 03FM11334, 03DM01797, 02FM07372, 02CM04108, 01LM08844, 01AM16024, 00306631

Catalog Number 71927103 (Size 3-4) Lot Numbers: 06AM00937,  04LM11514, 04KM18887, 04KM12225, 04FM08554, 03FM11350, 03FM11352, 03DM01798, 02FM07387, 02CM04110, 01LM08847, 00306632

Catalog Number 71927104 (Size 5-6) Lot Numbers: 04KM15385, 04LM09224, 03FM11353, 03DM01800, 02CM04114, 01LM08850, 00306635

Catalog Number 71927105 (Size 7-8) Lot Numbers: 06AM00940, 05KM07018, 04KM18889, 04LM09225, 04FM08555, 03FM11356, 03FM11355, 03DM01803, 02CM04121, 02CM04118, 01LM08854, 01LM08852, 01HM12256, 01BM14137, 00306638

RECALLING FIRM/MANUFACTURER

Recalling Firm:  Smith & Nephew, Inc., Memphis, TN,

Manufacturer:  Southeastern Technology, Inc., Murfreesboro, TN. 

REASON Tibial punches were not manufactured to specification and could break at the tip during use.

VOLUME OF PRODUCT IN COMMERCE 5,367 units

DISTRIBUTION Nationwide and Internationally

 

PRODUCT Axis-Shield DIASTAT Anti-CCP test kit, code FCCP200, 
CODE Lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09); and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8°C. The nonconforming kit component is the Negative Control (labeled 'CONTROL --'). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).

RECALLING FIRM/MANUFACTURER  Axis-Shield Diagnostics, Ltd., Dundee, Scotland, UK

REASON The preservative sodium azide used in the Kit Negative Control (part number FCOM175 was at the wrong concentration – the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.

VOLUME OF PRODUCT IN COMMERCE 2,288 kits

DISTRIBUTION Nationwide and Internationally

WEEK ENDING OCTOBER 21

PRODUCT Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Numbers: Catalogue numbers: 100118--Short, 14mm graft: #100121--Long, 14mm graft; #100129--Long, 18mm graft, 
CODE Serial numbers:104, 106
RECALLING FIRM/MANUFACTURER Thoratec Corp., Pleasanton, CA
REASON During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
VOLUME OF PRODUCT IN COMMERCE 24 units
DISTRIBUTION Nationwide and Australia

PRODUCT Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL, U770 GNDAL,
CODE Model U 770, serial number range: 6149310001 - 6149310005, 6151360001 - 6151360005, 6163290001 - 616330001. Model U770 AL, serial number range: 6099280001 - 6113410042, 6114760001 - 6127920006, 6128720001 - 6130360001, 6130510001 - 6135430002, 6136650001 - 6140860005, 6142190001 - 6142320001, 6142380001 - 6148440006, 6149320001 - 6151270004, 6152090001 - 6160890005, 6161480001 - 6162420010, 6163330001 - 6168440002, 6169170001 - 6171470001, 6171750001 - 6174080020, 6174750001 - 6177310002. U770-GNDAL, serial number range: 6113510001 - 6113510004, 6127970001 - 61279700015, 6130370001 - 6130370003, 6135440001, 6140870001 - 61408700010, 6142330001, 6160900001 - 61609000010, 6168450001 - 6168450004, 6171700001 - 6171720002, 6174710001 - 61747100012
RECALLING FIRM/MANUFACTURER Sunrise Medical CCG, Inc., Stevens Point, WI, 
REASON The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.
VOLUME OF PRODUCT IN COMMERCE 6,921 beds
DISTRIBUTION Nationwide and Canada

PRODUCT Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200
CODE All model P3200 VersaCare beds with the optional patient pendants P3207A01 or P3207A02.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN
REASON The patient pendant cord represents a potential trip hazard for the patient or the caregiver.
VOLUME OF PRODUCT IN COMMERCE 36,645 beds
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use
b) FSH Calibrators (LN 9C06-01), for in vitro diagnostic use,
c) Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use,
CODE
a) Lot# 33266Q100 Expiration Date 11/04/2006;
b) Lot # 33362Q100 Expiration Date 11/04/2006;
c) Lot # 33363Q100 Expiration Date 11/04/2006
RECALLING FIRM/MANUFACTURER Abbott Diagnostic International, Ltd., Barceloneta, PR, 
REASON Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
VOLUME OF PRODUCT IN COMMERCE 1,980 units
DISTRIBUTION Nationwide and Internationally

PRODUCT 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant, 
CODE Lot numbers 2006-12 AA through 2008-06 AB.
RECALLING FIRM/MANUFACTURER 3M Company / Medical Division, South St Paul MN, 
REASON 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
VOLUME OF PRODUCT IN COMMERCE 6,248 cases (4 boxes per case)
DISTRIBUTION Nationwide

PRODUCT Lumenis brand DuoTome SideLite(tm) 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01,
CODE Lot/Batch Numbers: 37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706, 37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706, 37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706, 37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706, 37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706, 37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706, 37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706, 37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706, 37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706, 37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706, 37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706, 37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706, 37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706, 37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706, 37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706, 37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706, 37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706, 37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706, 37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706, 37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706
RECALLING FIRM/MANUFACTURER Lumenis Inc., Santa Clara, CA
REASON Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
VOLUME OF PRODUCT IN COMMERCE 10,815 units
DISTRIBUTION Nationwide

PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J,
CODE AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.
RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc, Twinsburg, OH,
REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.
VOLUME OF PRODUCT IN COMMERCE 348 systems
DISTRIBUTION Nationwide and PR

PRODUCT Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart, 
CODE MF5124329
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc, Reading PA, 
Manufacturer: Arrow International, Inc., Mount Holly, NJ. 
REASON The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION MD, IL, MO, MA and United Kingdom

PRODUCT CR DX-S, Image Intensified Fluoroscopic X-ray system,
CODE Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC
Manufacturer: AGFA Corp., Mortsel, Belgium.
REASON Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION Nationwide

PRODUCT Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, CODE Serial numbers: PA0101 to PA0681
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO,
Manufacturer: Gambro Dasco S.p.A, Monitor Division, Medolla, Italy. 
REASON A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
VOLUME OF PRODUCT IN COMMERCE 154 units
DISTRIBUTION Nationwide

PRODUCT IMPAX® 5.2 Systems with CAD Capability (Computer Assisted Diagnosis), CODE
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC
REASON Failed CAD displayed as 'No Findings'.
VOLUME OF PRODUCT IN COMMERCE 20 Impax 5.2 Mammo licenses
DISTRIBUTION Nationwide

PRODUCT SmartSuction Harmony Powered Suction Device, Model number: HAR-E-115-US, 
CODE Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
RECALLING FIRM/MANUFACTURER Haemonetics Corp., Eastern Maine Medical Center, Braintree, MA
REASON Faulty circuit board may short circuit and cause electric shock to operator.
VOLUME OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
CODE Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integrated Orbital Implants Inc, San Diego, CA, 
Manufacturer: Interpore Cross International Inc, Irvine CA. 
REASON The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION Finland and France

Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time

Roche Diagnostics is notifying users of an important recall of all CoaguChek® PT test strips currently in the market, due to a potential for a test strip defect that may cause falsely elevated test results. The company has identified the root cause and is instituting corrective action with highest priority. 

CoaguChek PT test strips are used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners. 

Roche Diagnostics has determined the potential for a test strip defect when insufficient active ingredient (thromboplastin) is applied to the test strip, possibly causing falsely elevated results. As a result of the unpredictable positive bias, patient test results may be falsely elevated. This can result in an incorrect dose of anti-coagulant or unnecessary corrective measures to reduce the effect of circulating anti-coagulants. Both incorrect treatment choices could put patients at risk for blood clots.

Roche Diagnostics is notifying all home users of the CoaguChek PT test strip to immediately discontinue use of and discard the product as well as to consult with their health care provider to determine alternate testing methodologies and clinical implications. U.S. customers with questions or concerns should call Roche Diagnostics' Point-of-Care Technical Service at 1-800-820-0995.

Roche Diagnostics is notifying all health care professionals who use the CoaguChek PT test strip to institute 'duplicate testing' - or two strips on each patient - using different lot numbers to reduce the risk of bias. If health care professionals require another lot to enable duplicate testing, they are encouraged to call their medical supply distributor. For general questions, health care professionals should call the company's Point-of-Care Technical Service Center at 1-800-820-0995. These actions must remain in place until the issue has been resolved and health care professionals are supplied with unaffected replacement product.

Letters are being sent to customers, providers and physicians – including additional information regarding this voluntary action.

WEEK ENDING OCTOBER 28

PRODUCT Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, 
CODE
Model 8627-10, serial numbers: NGE000001 - NGE000242R,
Model 8627-18, serial numbers: NGF000001 - NGF003266R,
Model 8627L-10, serial numbers: NGG000001R - NGG000068R,
Model 8627L-18, serial numbers: NGH000001R - NGH001780R
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN
Manufacturer: Medtronic, Inc. Cardiac Rhythm Management, Minneapolis, MN. 
REASON The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.
VOLUME OF PRODUCT IN COMMERCE 4,317 pumps
DISTRIBUTION Nationwide and Internationally

PRODUCT ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed, CODE Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Extended Care Air Therapy Systems Inc, Roseville OH,
Manufacturer: GF Health Products, Inc., Fond Du Lac WI.
REASON Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall.
VOLUME OF PRODUCT IN COMMERCE 102 beds
DISTRIBUTION KS, TN, MI, PA, and LA

PRODUCT BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm, Catalog number 367352, Catalog number 367352, Catalog number 367352, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, 
CODE Lot # 6100596, Lot # 6100597, Lot # 6152413, Lot # 6090251, Lot # 6094813, Lot # 6094840, Lot # 6111757, Lot # 6121663, Lot # 6146186
RECALLING FIRM/MANUFACTURER Becton Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: BD Preanalytical Solutions, Sumter, SC.
REASON A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.
VOLUME OF PRODUCT IN COMMERCE 110,300 units
DISTRIBUTION Nationwide

PRODUCT
a) Medline Strider Maxi 3 Scooter; a three wheeled battery
operated scooter; model MDS807600 - red and MDS807600B -- blue, 
b) Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter;
model MDS807650 - red and MDS807650B -- blue,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc., Mundelein, IL,
Manufacturer: Changzhou Kwang Yang Motor Co., Ltd, Changzhou, Jangsu, China. REASON Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
VOLUME OF PRODUCT IN COMMERCE 296 scooters
DISTRIBUTION Nationwide

PRODUCT
a) Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors, 
b) Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors,
CODE Serial numbers 624EZ0010 through 624EZ0513
RECALLING FIRM/MANUFACTURER Eagle Parts and Products, Augusta, GA, REASON The wheel hub bolts may loosen resulting in the wheels coming off.
VOLUME OF PRODUCT IN COMMERCE 365 units
DISTRIBUTION Nationwide

PRODUCT GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210,
CODE Serial numbers E9-0002-G, E9-0004-G, E9-0014-G, E9-0032-G, E9-0035-G, E9-0036-G, E9-0040-G, E9-0041-G, E9-0042-G, ES-0002-G, ES-0003-G, ES-0013-G, ES-0014-G, ES-0015-G, ES-0016-G, ES-0018-G, ES-0020-G, ES-0021-G, ES-0023-G, ES-0024-G, ES-0025-G, ES-0026-G, ES-0027-G, ES-0028-G, ES-0031-G, ES-0032-G, ES-0033-G, ES-0034-G, ES-0035-G, ES-0040-G, ES-0041-G, ES-0042-G, ES-0043-G, ES-0044-G, ES-0081-G, ES-0082-G, ES-0083-G, ES-0084-G, ES-0085-G, ES-0086-G.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT, 
REASON Missing, mixed or lost patient images may result after X-ray procedures. Navigational error.
VOLUME OF PRODUCT IN COMMERCE 40 units
DISTRIBUTION Nationwide and Internationally

PRODUCT GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210,
CODE Serial numbers: E2-0001 thru E2-0065, E2-0066-CH, E2-0067 thru E2-0152, E2-0156 thru E2-0159, E2-0166, E2-7001-MH thru E2-7033-MH, E2-7034-CMH, E2-7035-MH thru E2-7056-MH, E9-0001, E9-0003, E9-0005 thru E9-0013, E9-0015 thru E9-0031, E9-0033, E9-0034, E9-0038, E9-0039, E9-0043 thru E9-0082, E9-00084, E9-0086, E9-0087, E9-0096, E9-0097, E9-0104, E9-0105, E9-0106, E9-0107, ES-0001, ES-0004, ES-0005, ES-0006, ES-0007-C, ES-0008, ES-0009, ES-0010, ES-0011-H, ES-0012-H, ES-0017, ES-0019, ES-0022-CH, ES-0029-CH, ES-0030, ES-0036-CH, ES-0037, ES-0038, ES-0039, ES-0045-H, ES-0046-CH, ES-0047, ES-0048, ES-0049-H, ES-0050 thru ES-0059, ES-0060-H, ES-0061, ES-0062-H, ES-0063-H, ES-0064, ES-0065, ES-0066-CH, ES-0067 thru ES-0080, ES-0091-H, ES-0092-CH, ES-0093, ES-0094, ES-0095, ES-0096, ES-0099-CH, ES-0100-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0106, ES-0107, ES-7001-CMH, ES-7002-MH, ES-7003-MH, ES-7004-CMH, ES-7005-MH, ES-7006-CMH thru ES-7013-CMH, ES-7014-MH thru ES-7018-MH, ES-7019-CMH, ES-7020-CMH, ES-7022-CMH, ES-7023-CMH, ES-7024-CMH, ES-7025-CMH, ES-7026-MH, ES-7027-MH.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT, 
REASON X-ray system may lose or mix images and/or lose patient data.
VOLUME OF PRODUCT IN COMMERCE 388 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45, 
CODE Lot number: S2964090
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioplate Inc, Los Angeles CA,
Manufacturer: Midwest Plastic Components, Minneapolis, MN. 
REASON Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
VOLUME OF PRODUCT IN COMMERCE 36 units
DISTRIBUTION Nationwide

PRODUCT 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex,
CODE Lot: 22-010-9D
RECALLING FIRM/MANUFACTURER Excelsior Medical Corp., Neptune, NJ,
REASON The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
VOLUME OF PRODUCT IN COMMERCE 466,000 syringes
DISTRIBUTION Nationwide and Internationally

PRODUCT Doc-U-Dose Prescription Management System, Item #8-PKIT, a daily activity assist device under 21 C.F.R. 890.5050. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime,'' 
CODE Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eatonform, Inc., Dayton, OH,
Manufacturer: Ward/Kraft, Inc., Fort Scott, KN. 
REASON Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.
VOLUME OF PRODUCT IN COMMERCE 913 devices
DISTRIBUTION Nationwide

PRODUCT Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN 1018246,
CODE Serial numbers: VSF5200456 VSF5200470 VSF5200474 VSF5200491 VSF5200520 VSF5200521 VSF5200524 VSF5200529 VSF5200534 VSF5200190 VSF5200224 VSF5200235 VSF5200292 VSF5200302 VSF5200319 VSF5200325 VSF5200338 VSF5200345 VSF5200350 VSF5200351 VSF5200353 VSF5200355 VSF5200356 VSF5200460 VSF5200511 VSF5200512 VSF5200530 VSF5200535 VSF5200536 VSF5200538 VSF5200542 VSF5200545 VSF5200548 VSF5200552 VSF5200553 VS3007083 VS3007154 VS3007171 VSF5200343 VSF5202005 VS3005661 VS3008643 VS3008863 VS3008976 VS3006424 VS3007284 VS3007684 VS3008702 VS3008781 VS3007757 VS3008853 VS3008945 VS3008989 VSF5200297 VSF5200340 VSF5200344 VSF5200406 VSF5201510 VSF5202096 VS3004635 VS3004813 VS3005642 VS3005696 VS3005810 VS3005897 VS3005945 VS3006191 VS3006213 VS3006220 VS3006385 VS3006546 VS3006549 VS3006578 VS3006584 VS3006587 VS3007199 VS3007215 VS3007296 VS3007304 VS3007397 VS3007512 VS3007712 VS3007715 VS3007771 VS3007777 VS3007823 VS3007834 VS3007896 VS3007908 VS3008558 VS3008567 VS3008646 VSF5200352 VSF5200363 VSF5200373 VSF5200380 VSF5200382 VSF5200391 VSF5200392 VSF5200240 VSF5200303 VSF5200317 VSF5200322 VSF5200327 VSF5200328 VSF5200330 VSF5200336 VSF5200407 VSF5200540 VSF5200541 VSF5200547 VSF5200551 VSF5200554 VSF5200556 VSF5200569 VSF5200570 VSF5200623 VSF5200632 VSF5200634 VSF5200637 VSF5200638 VSF5200641 VSF5200648 VSF5200789 VSF5200793 VSF5200796 VSF5200799 VSF5200802 VSF5200805 VSF5200807 VSF5200808 VSF5200809 VSF5200810 VSF5200811 VSF5200812 VSF5200813 VSF5200815 VSF5200817 VSF5200818 VSF5200819 VSF5200820 VSF5200823 VSF5200824 VSF5200825 VSF5200827 VSF5200836 VSF5200839 VSF5200842 VSF5200846 VSF5201231 VSF5201242 VSF5201254 VSF5201255 VSF5201256 VSF5201258 VSF5201273 VSF5201557 VS3004805 VS3006192 VS3006193 VS3006194 VS3006195 VS3006202 VS3006206 VS3006211 VS3006219 VS3006333 VS3006337 VS3006349 VS3006386 VS3006394 VS3006396 VS3006399 VS3006400 VS3006402 VS3006408 VS3006414 VS3006421 VS3006637 VS3007177 VS3007292 VS3007429 VSF5200293 VSF5200305 VSF5200308 VSF5200313 VSF5200316 VSF5200321 VSF5200348 VSF5200354 VSF5200359 VSF5200364 VSF5200369 VSF5200400 VSF5200404 VSF5202388 VS3004803 VS3004916 VS3005626 VS3005797 VS3005852 VS3005865 VS3005902 VS3005984 VS3006200 VS3006218 VS3006634 VS3007103 VS3007542 VS3007545 VS3007605 VS3007620 VSF5200276 VSF5200294 VSF5200298 VSF5200301 VSF5200306 VSF5200312 VSF5200314 VSF5200318 VSF5200333 VSF5200337 VSF5200349 VSF5200361 VSF5200398 VSF5200402 VSF5200450 VSF5200457 VSF5200466 VSF5200468 VSF5200469 VSF5200472 VSF5200492 VSF5200496 VSF5200537 VSF5200546 VSF5200549 VSF5200571 VSF5200608 VSF5200611 VSF5200615 VSF5200625 VSF5200628 VS3006533 VS3006642 VS3007477 VS3007485 VS3007486 VS3007540 VS3007546 VS3007564 VS3007611 VS3007613 VS3007773 VS3007806 VS3007851 VS3008688 VS3008878 VS3005888 VS3006525 VS3006538 VS3006545 VS3006556 VS3006560 VS3006581 VS3006585 VS3006654 VS3006668 VS3006694 VS3007005 VS3007010 VS3007057 VS3007126 VS3007127 VS3007132 VS3007134 VS3007151 VS3007152 VS3006197 VS3006217 VS3006222 VS3007038 VS3007052 VSF5200060 VSF5200061 VSF5200063 VSF5200064 VSF5200065 VSF5200066 VSF5200067 VSF5200069 VSF5200071 VSF5200073 VSF5200074 VSF5200075 VSF5200076 VSF5200077 VSF5200078 VSF5200079 VSF5200080 VSF5200081 VSF5200082 VSF5200083 VSF5200084 VSF5200085 VSF5200086 VSF5200087 VSF5200088 VSF5200089 VSF5200091 VSF5200092 VSF5200093 VSF5200094 VSF5200095 VSF5200130 VSF5200192 VSF5200193 VSF5200196 VSF5200206 VSF5200229 VSF5200237 VSF5200254 VSF5200260 VSF5200261 VSF5200266 VSF5200268 VSF5200273 VSF5200274 VSF5200275 VSF5200278 VSF5200279 VSF5200280 VSF5200285 VSF5200287 VSF5200288 VSF5200289 VSF5200300 VSF5200309 VSF5200310 VSF5200323 VSF5200332 VSF5200334 VSF5200558 VSF5200562 VSF5200564 VSF5200565 VSF5200568 VSF5200828 VSF5200887 VSF5200894 VSF5200902 VSF5200903 VSF5200904 VSF5200905 VSF5200907 VSF5200911 VSF5200913 VSF5200928 VSF5200929 VSF5200930 VSF5200932 VSF5200934 VSF5200937 VSF5200942 VSF5200943 VSF5200944 VSF5200945 VSF5200946 VSF5200948 VSF5200950 VSF5200952 VSF5200953 VSF5200954 VSF5200955 VSF5200959 VSF5200960 VSF5200961 VSF5200962 VSF5200963 VSF5200964 VSF5200965 VSF5200966 VSF5200967 VSF5200968 VSF5200971 VSF5200973 VSF5200974 VSF5200975 VSF5200976 VSF5200977 VSF5200978 VSF5200985 VSF5200986 VSF5200987 VSF5200988 VSF5200989 VSF5200990 VSF5200991 VSF5200992 VSF5200994 VSF5201049 VSF5201056 VSF5201057 VSF5201066 VSF5201071 VSF5201075 VSF5201076 VSF5201079 VSF5201080 VSF5201082 VSF5201085 VSF5201086 VSF5201089 VSF5201093 VSF5201094 VSF5201095 VSF5201099 VSF5201100 VSF5201101 VSF5201105 VSF5201106 VSF5201108 VSF5201110 VSF5201111 VSF5201115 VSF5201116 VSF5201117 VSF5201118 VSF5202405 VSF5202416 VSF5202423 VSF5202437 VS3004618 VS3004668 VS3004986 VS3005762 VS3005804 VS3005816 VS3005817 VS3005822 VS3005908 VS3006190 VS3006215 VS3006529 VS3006552 VS3006666 VS3007012 VS3007014 VS3007145 VS3007168 VS3007221 VS3007274 VS3007299 VS3007413 VS3007439 VS3007507 VS3007582 VS3007753 VS3007866 VS3007880 VS3007893 VS3007898 VSF5200357 VSF5200360 VSF5200374 VSF5200378 VSF5200388 VSF5200412 VSF5200476 VSF5200481 VSF5200508 VSF5200527 VSF5200531 VSF5200532 VSF5200533 VS3004925 VS3007190 VS3007193 VS3007527 VS3007280 VS3007297 VS3007383 VS3007541 VS3007904 VS3008640 VS3008660 VS3008665 VS3008786 VS3008802 VS3008845 VS3008846 VS3008852 VSF5200090 VSF5200096 VSF5200097 VSF5200098 VSF5200099 VSF5200100 VSF5200101 VSF5200102 VSF5200103 VSF5200104 VSF5200105 VSF5200106 VSF5200107 VSF5200108 VSF5200109 VSF5200110 VSF5200111 VSF5200112 VSF5200113 VSF5200114 VSF5200115 VSF5200116 VSF5200118 VSF5200119 VSF5200121 VSF5200122 VSF5200126 VSF5200133 VSF5200218 VSF5200225 VSF5200231 VSF5200241 VSF5200258 VSF5200259 VSF5200262 VSF5200265 VSF5200270 VSF5200272 VSF5200281 VSF5200283 VSF5200284 VSF5200286 VSF5200290 VSF5200291 VSF5200304 VSF5200528 VSF5200539 VSF5200544 VSF5200550 VSF5200557 VSF5200573 VSF5200592 VSF5200593 VSF5200594 VSF5200595 VSF5200658 VSF5200659 VSF5200795 VSF5200806 VSF5200831 VSF5200834 VSF5200841 VSF5200843 VSF5200844 VSF5200845 VSF5200852 VSF5200853 VSF5200854 VSF5200856 VSF5200857 VSF5200862 VSF5200863 VSF5200864 VSF5200865 VSF5200866 VSF5200867 VSF5200868 VSF5200871 VSF5200873 VSF5200874 VSF5200875 VSF5200876 VSF5200881 VSF5200882 VSF5200883 VSF5200884 VSF5200885 VSF5200886 VSF5200895 VSF5200908 VSF5200909 VSF5200993 VSF5201002 VSF5201003 VSF5201005 VSF5201008 VSF5201010 VSF5201011 VSF5201012 VSF5201013 VSF5201014 VSF5201015 VSF5201017 VSF5201020 VSF5201024 VSF5201026 VSF5201027 VSF5201029 VSF5201030 VSF5201031 VSF5201032 VSF5201034 VSF5201035 VSF5201036 VSF5201037 VSF5201040 VSF5201043 VSF5201044 VSF5201045 VSF5201048 VSF5201050 VSF5201051 VSF5201055 VSF5201058 VSF5201059 VSF5201060 VSF5201061 VSF5201062 VSF5201063 VSF5201070 VSF5201072 VSF5201074 VSF5201077 VSF5201078 VSF5201081 VSF5201090 VSF5201091 VSF5201098 VSF5201121 VSF5201130 VSF5201131 VSF5201133 VSF5201134 VSF5201136 VSF5201137 VSF5201138 VSF5201143 VSF5201147 VSF5201148 VSF5201149 VSF5201150 VSF5201151 VSF5201152 VSF5201153 VSF5201154 VSF5201158 VSF5201159 VSF5201160 VSF5201161 VSF5201162 VSF5201163 VSF5201164 VSF5201165 VSF5201167 VSF5201168 VSF5201169 VSF5201170 VSF5201172 VSF5201175 VSF5201178 VSF5201180 VSF5201181 VSF5201182 VSF5201183 VSF5201184 VSF5201185 VSF5201186 VSF5201187 VSF5201188 VSF5201190 VSF5201191 VSF5201192 VSF5201195 VSF5201505 VSF5201522 VSF5201523 VSF5201530 VSF5201541 VSF5201545 VSF5201547 VSF5201750 VSF5201751 VSF5201758 VSF5202057 VSF5202116 VSF5202238 VSF5202248 VSF5202252 VSF5202255 VSF5202395 VS3005820 VS3005893 VS3005894 VS3005899 VS3005905 VS3005925 VS3005942 VS3007006 VS3007016 VS3007029 VS3007047 VS3007054 VS3007059 VS3007070 VS3007082 VS3007102 VS3007112 VS3007125 VS3007161 VS3007173 VS3007192 VS3007236 VS3007240 VS3007241 VS3007257 VS3007316 VS3007317 VS3007321 VS3007325 VS3007328 VS3007351 VS3007361 VS3007367 VS3007390 VS3007406 VS3007419 VS3007424 VS3007431 VS3007440 VS3007444 VS3007465 VS3007466 VS3007468 VS3007482 VS3007495 VS3007500 VS3007511 VS3007521 VS3007522 VS3007528 VS3007539 VS3007547 VS3007548 VS3007557 VS3007558 VS3007561 VS3007573 VS3007584 VS3007585 VS3007592 VS3007595 VS3007602 VS3007616 VS3007617 VS3007621 VS3007632 VS3007648 VS3007653 VS3007655 VS3007656 VS3007667 VS3007676 VS3007678 VS3007695 VS3007735 VS3007737 VS3007803 VS3007862 VS3007873 VS3007884 VS3007899 VS3007910 VS3007922 VS3008523 VS3008537 VS3008539 VS3008545 VS3008556 VS3008587 VS3008597 VS3008602 VS3008649 VS3008653 VS3008710 VS3008826 VS3008833 VS3008877 VS3008885 VS3008897 VS3008901 VS3008920 VS3008972 VS3008975 VS3004565 VS3004648 VS3004689 VS3004729 VS3004830 VS3004942 VS3004956 VS3004974 VS3004983 VS3005041 VS3005627 VS3005656 VS3005659 VS3005665 VS3005681 VS3005689 VS3005690 VS3005702 VS3005719 VS3005731 VS3005752 VS3005778 VS3005789 VS3005800 VS3005801 VS3005802 VS3005806 VS3005811 VS3005813 VS3005814 VS3005815 VS3005819 VS3005823 VS3005824 VS3005828 VS3005834 VSF5201240 VSF5201244 VSF5201257 VSF5201500 VSF5201501 VSF5201504 VSF5201506 VSF5201525 VSF5201569 VSF5202394 VS3007819 VS3008884 VS3004976 VS3005856 VS3006199 VS3006203 VS3007530 VSF5201260 VSF5201268 VS3005695 VS3005784 VS3005909 VS3006679 VS3007563 VS3008622 VS3006562 VS3007049 VS3007639 VS3007659 VSF5201550 VSF5201552 VSF5202104 VSF5202115 VS3007026 VS3005886 VS3007106 VS3007438 VS3006998 VS3007066 VS3007041 VS3007181 VS3007263 VS3007672 VS3007895 VSF5200326 VSF5201746 VS3005869 VS3007320 VS3007409 VS3007484 VS3007502 VS3007526 VSF5201193 VSF5201199 VSF5201201 VSF5201202 VSF5201203 VSF5201204 VSF5202055 VS3007324 VS3007556 VS3008912 VSF5202124 VS3005668 VS3005691 VS3007208 VS3008696 VS3008541 VSF5201595 VSF5201710 VSF5201974 VS3006555 VS3006559 VS3007301 VS3007630 VS3007638 VS3007670 VS3008942 VS3007501 VS3007717 VS3006550 VS3006566 VS3006643 VS3006650 VS3006652 VS3006657 VS3007024 VS3007204 VS3007206 VS3007272 VS3007305 VS3007508 VS3007600 VS3009019 VSF5200358 VSF5200414 VSF5200339 VSF5200347 VSF5200366 VSF5200367 VSF5200368 VSF5200370 VSF5200376 VSF5200377 VSF5200386 VSF5200387 VSF5200395 VSF5200397 VSF5200401 VSF5200416 VSF5200462 VSF5200464 VSF5200465 VSF5200467 VSF5200475 VSF5200480 VSF5200498 VS3008584 VS3007814
RECALLING FIRM/MANUFACTURER Respironics California, Inc., Carlsbad, CA, REASON This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases, in which a fan also failed, have shown signs of fire damage.
VOLUME OF PRODUCT IN COMMERCE 950 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Favius GS Anesthesia Machine. Catalog number 8604699,
CODE All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, 
Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. 
REASON One of four casters may break loose from chassis.
VOLUME OF PRODUCT IN COMMERCE 429 units
DISTRIBUTION Nationwide and Canada

PRODUCT DynaRad Phantom Portable X-Ray System; Phantom model (PH-150-CM & PH-150-G), 
CODE Generator serial numbers: 03460-1003, 03477-1003, 03499-1003, 03550-1003, 03647-1003, 03704-1003, 03734-1003, 03744-1003, 03759-1003, 03765-1003, 03823-1003, 03938-1103, 03941-1103, 03953-1003, 04227-1103, 04282-1203, 04303-1203, 04330-1203, 04477-1203, 04497-1203, 04666-1203, 04704-1203, 00013-0104, 00035-0104, 00107-0104, 00122-0104, 00127-0104, 00188-0104, 00192-0104, 00332-0104, 00336-0104, 00405-0104, 00417-0104, 00430-0104, 00474-0104, 00545-0204, 00555-0204, 00568-0204, 00709-0204, 00719-0204, 00741-0204, 00754-0204, 00776-0204, 00995-0304, 00999-0304, 01101-0304, 01291-0304, 01295-0304, 01369-0304, 01423-0404, 01450-0404, 01468-0404, 01473-0404
RECALLING FIRM/MANUFACTURER Del Medical Systems Group, Franklin Park, IL, 
REASON The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.
VOLUME OF PRODUCT IN COMMERCE 53 units
DISTRIBUTION Nationwide and Thailand

PRODUCT Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic), 
CODE Lot Numbers: CN04J012, CN 06A003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, 
Manufacturer: Centex Machining, Inc., Round Rock, TX. 
REASON Bone reamer may not have a cutting surface on the tip.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION Nationwide

PRODUCT

a) AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh
b) AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a
self-expandable, double disc device made from a Nitinol wire mesh,
CODE
a) Lot number M06B01-52, serial numbers 190477 -- 190494;
b) Lot number M06B01-58, serial numbers 190495 - 190512
RECALLING FIRM/MANUFACTURER AGA Medical Corporation, Golden Valley MN, 
REASON AMPLATZER PFO Occluders were mislabeled with incorrect device size. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.
VOLUME OF PRODUCT IN COMMERCE 36 units
DISTRIBUTION Internationally

PRODUCT GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application), 
CODE Software version 3.8 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Healthcare, Wauwatosa, WI,
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. 
REASON When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur.
VOLUME OF PRODUCT IN COMMERCE 5,203 systems
DISTRIBUTION Nationwide and Internationally

PRODUCT DeVilbiss iFill Personal Oxygen Station model number 535D, 
CODE Serial numbers AD01145 through AD01462
RECALLING FIRM/MANUFACTURER Sunrise Medical, Somerset, PA,
REASON Potential for oxygen cylinders to not fill completely.
VOLUME OF PRODUCT IN COMMERCE 252 units
DISTRIBUTION Nationwide

PRODUCT Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, REF 60A 160
CODE Lots: 1037018 and 1045416
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary IN
REASON The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
VOLUME OF PRODUCT IN COMMERCE 71 devices
DISTRIBUTION Nationwide

PRODUCT Stic Kit Needle Containment Device, Model EMI 82691, packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band, 
CODE Lot codes: 070505 and 110602
RECALLING FIRM/MANUFACTURER
Recalling Firm: EM Innovations, Inc. Galloway, OH, 
Manufacturer: Enterprise Plastics, Kent, OH. 
REASON The firm failed to include User Instructions with the Stic Kit Needle Containment Device, when shipped.
VOLUME OF PRODUCT IN COMMERCE 2,462 devices
DISTRIBUTION Nationwide