AUGUST 2010

WEEK ENDING AUGUST 28

PRODUCT 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. 
CODE
Lot: LU8QJ000
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, .
Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. 
REASON Monitor fell from the mounting bracket used to support the monitor
VOLUME OF PRODUCT IN COMMERCE
805 units
DISTRIBUTION
Nationwide and Canada

PRODUCT
1) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 

2) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 

3) Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 

4) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 

5) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 

6) Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO. Intended to facilitate the placement of devices during diagnostic and interventional procedures. 
CODE
1) Lot Number K131823;
2) Lot Number K131824;
3) Lot Number K131832;
4) Lot Number K130761 (3 year expiry), P116003 (1 year expiry);
5) Lot Number K131835;
6) Lot Number K131837
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT,
Manufacturer: Merit Medical Ireland Ltd., Galway, Ireland. 
REASON Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
VOLUME OF PRODUCT IN COMMERCE
964 units
DISTRIBUTION
Nationwide

PRODUCT RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes. 
CODE
Test kit lot numbers: H9KHR002, Exp 07/2010 and BOKHR001, Exp 1/2011; RAF 10-016
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, 
REASON An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.
VOLUME OF PRODUCT IN COMMERCE
Lot B0KHR001: 13 in US, 3 out of US, Lot H9KHR002: 25 in US
DISTRIBUTION
CA, NC, TX, FL, MD, OK, NY, NJ and Italy

PRODUCT Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; Made in Dominican Republic; REF CCH2220 For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone. 
CODE Lot D09121745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 2200 Inc., Waukegan, IL,
Manufacturer: Cardinal Health, Santo Domingo, Dominican Republic.
REASON The introducer needle is only 10 cm in length instead of the required 15 cm.
VOLUME OF PRODUCT IN COMMERCE
115 units
DISTRIBUTION
CA, FL, GA, IL, KY, MA, NJ, NY, PA

PRODUCT International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic 15 vials For performance of Level 1 quality control ACT-LR test curettes’ on the Hemochron Microcoagulation Systems. CODE Lot number: M9DNL055, exp. 9/2010
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ,
REASON The package insert for the direct Check Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR curettes’.
VOLUME OF PRODUCT IN COMMERCE 122 boxes in US, 1 box out of US. Each box contains 15 vials
DISTRIBUTION
Nationwide and Belgium

PRODUCT
1) Philips Intellivue Patient Monitor Model MP60 (M8005A). 

2) Philips Intellivue Patient Monitor Model MP70 (M8007A). 
CODE
1) Serial Numbers: DE22701289 - DE843 16576;
2) Serial Numbers: DE22702728 - DE84399581
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, 
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. 
REASON Additional Instruction for Use for Intellivue MP60/MP70 to prevent monitors from becoming loose and detaching from the mounting arm.
VOLUME OF PRODUCT IN COMMERCE
93, 548 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component. CODE Lot: M402080
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, 
REASON A knee implant labeled as left was opened and the package actually contained a right knee implant.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION IN and Japan

PRODUCT Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilator support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support. 
CODE
Units: Y09D1922 Y09H0564 Y09H0565 Y09K0491 Y09K0492 Y09S1283 Y09S1284 Y10A1230
RECALLING FIRM/MANUFACTURER
Recalling Firm: CareFusion 203, Inc., Minneapolis, MN, 
Manufacturer: Productos Urologos de Mexico S.A. de C.V., Mexicali, Baja California, Mexico. 
REASON CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both audible and visual alarm indicators to alert the Health Care Professional to provide alternative ventilation as required.
VOLUME OF PRODUCT IN COMMERCE
200 boxes (5 ea)
DISTRIBUTION
Nationwide

PRODUCT Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically. 

CODE
Lot Serial No IJX061043P IJX061063P IJX067150P IJX067158P IJX067162P IJX013664P IJX013831P IJX014701P IJX014899P IJX015305P IJX015406P IJX015768P IJX062594P IJX062607P IJX062654P IJX062655P IJX062656P IJX062661P IJX062669P IJX062670P IJX062672P IJX062673P IJX062674P IJX062683P IJX062698P IJX062701P IJX062706P IJX062716P IJX062727P IJX062734P IJX062736P IJX062738P IJX062739P IJX062741P IJX062747P IJX062763P IJX062764P
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, 
Manufacturer: Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. 
REASON Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue.
VOLUME OF PRODUCT IN COMMERCE 37 units
DISTRIBUTION
Australia and Canada

PRODUCT
1) Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. 

2) Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. 

3) Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery. 

4) Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile. CODE
1) Lots: 60492194, 60531068, 60530835, 60724676, 60680532, 60770940, 60796676, 60904592, 61195210, 61076505, 61424513 and 61424514;

2) Lots: 60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530;

3) Lots: 60492196, 60531086, 60703467, 60667441, 60728123, 60767106, 60787931, 60808260, 60904605, 61024439, 61143012, 61217116 and 61355988;

4) Lots: 60492197, 60704071, 60667465, 60728122, 60770944, 60796679, 60862513, 61081548, 61143008, and 61324533
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, 
Manufacturer: Zimmer Trabecular Metal Technology, Inc., Parsippany, NJ.
REASON The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
VOLUME OF PRODUCT IN COMMERCE
1,972 units
DISTRIBUTION
Nationwide, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland

WEEK ENDING AUGUST 21

Integra Issues URGENT Worldwide Recall of NeuroBalloonTM Catheter 

Integra LifeSciences Corporation, Plainsboro, New Jersey, is recalling the NeuroBalloon Catheter. There were a total of 1,924 units distributed, 258 in the United States of America 1,586 in the European Union and 80 in countries. A total of eight (8) complaints regarding the inflation or deflation of the NeuroBalloon Catheter were received by Integra. 

The recall includes the following catalog numbers and lot identifications:
NeuroBalloon Catheter, Catalog Number 7CBD10, Lot Numbers 0157983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, 0161857.

Affected product was distributed by Integra (USA) in: USA (Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Pennsylvania, Texas, Utah, Vermont), Argentina, Australia, Canada, France, Taiwan, and United Kingdom Integra has notified its distributors and customers by overnight mail on July 2, 2010 and has arranged for return of all unused recalled products.

Healthcare practitioners with questions may contact the company at 1-800-654-2873 (Follow Returns & Repairs Prompt) Monday through Friday, 8:00 am to 5:00 pm (EST).

PRODUCT Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air. CODE
Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC,
Manufacturer: Teleflex Medical, Perak, Malaysia. 
REASON The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-respiratory arrest.
VOLUME OF PRODUCT IN COMMERCE
48,078 units
DISTRIBUTION
CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Japan

PRODUCT Ikaria INOMAX DS Drug Delivery System, model 10003. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the aspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. 
CODE
Serial numbers: DS20070005, DS20070008, DS20070009, DS20070010, DS20070011, DS20070012, DS20070014, DS20070015, DS20070016, DS20070017, DS20070019, DS20070020, DS20070021, DS20070022, DS20070023, DS20070024, DS20070028, DS20070030, DS20070031, DS20070032, DS20070033, DS20070034, DS20070035, DS20070037, DS20070041, DS20070045, DS20070046, DS20070048, DS20070049, DS20070050, DS20070051, DS20070053, DS20070057, DS20070058, DS20070059, DS20070061, DS20070062, DS20070063, DS20070064, DS20070068, DS20070069, DS20070070, DS20070072, DS20070073, DS20070075, DS20070076, DS20070077, DS20070078, DS20070079, DS20070080, DS20070081, DS20070082, DS20070083, DS20070084, DS20070085, DS20070086, DS20070087, DS20070092, DS20070093, DS20070095, DS20070096, DS20070097, DS20070100, DS20070103, DS20070104, DS20070106, DS20070107, DS20070109, DS20070114, DS20070115, DS20070116, DS20070117, DS20070118, DS20070119, DS20070121, DS20070122, DS20070123, DS20070125, DS20070127, DS20070128, DS20070129, DS20070130, DS20070132, DS20070134, DS20070135, DS20070138, DS20070139, DS20070140, DS20070141, DS20070142, DS20070145, DS20070146, DS20070147, DS20070148, DS20070149, DS20070150, DS20070153, DS20070154, DS20070156, DS20070157, DS20070158, DS20070160, DS20070161, DS20070163, DS20070164, DS20070166, DS20070167, DS20070168, DS20070170, DS20070171, DS20070172, DS20070173, DS20070174, DS20070179, DS20070181, DS20070182, DS20070183, DS20070184, DS20070185, DS20070186, DS20070187, DS20070188, DS20070191, DS20070192, DS20070194, DS20070195, DS20070196, DS20070197, DS20070198, DS20070201, DS20070202, DS20070203, DS20070204, DS20070207, DS20070208, DS20070210, DS20070212, DS20070213, DS20070215, DS20070216, DS20070217, DS20070219, DS20070220, DS20070221, DS20070223, DS20070224, DS20070225, DS20070226, DS20070227, DS20070229, DS20070230, DS20070231, DS20070232, DS20070233, DS20070236, DS20070237, DS20070239, DS20070240, DS20070243, DS20070244, DS20070245, DS20070247, DS20070249, DS20070251, DS20070252, DS20070253, DS20070254, DS20070255, DS20070256, DS20070257, DS20070258, DS20070259, DS20070260, DS20070261, DS20070262, DS20070265, DS20070267, DS20070268, DS20070272, DS20070274, DS20070275, DS20070276, DS20070278, DS20070279, DS20070280, DS20070281, DS20070283, DS20080001, DS20080004, DS20080005, DS20080006, DS20080009, DS20080011, DS20080016, DS20080019, DS20080020, DS20080021, DS20080022, DS20080023, DS20080025, DS20080026, DS20080027, DS20080028, DS20080029, DS20080030, DS20080033, DS20080034, DS20080035, DS20080036, DS20080038, DS20080040, DS20080041, DS20080043, DS20080045, DS20080046, DS20080047, DS20080048, DS20080049, DS20080050, DS20080051, DS20080052, DS20080053, DS20080054, DS20080055, DS20080056, DS20080057, DS20080058, DS20080061, DS20080063, DS20080064, DS20080067, DS20080068, DS20080069, DS20080072, DS20080073, DS20080074, DS20080076, DS20080077, DS20080079, DS20080080, DS20080081, DS20080082, DS20080084, DS20080086, DS20080087, DS20080088, DS20080089, DS20080090, DS20080092, DS20080095, DS20080097, DS20080098, DS20080099, DS20080100, DS20080102, DS20080103, DS20080104, DS20080105, DS20080106, DS20080107, DS20080109, DS20080111, DS20080112, DS20080113, DS20080114, DS20080115, DS20080116, DS20080117, DS20080118, DS20080119, DS20080120, DS20080121, DS20080122, DS20080123, DS20080124, DS20080125, DS20080127, DS20080128, DS20080129, DS20080130, DS20080132, DS20080133, DS20080134, DS20080135, DS20080136, DS20080137, DS20080138, DS20080141, DS20080142, DS20080143, DS20080144, DS20080145, DS20080146, DS20080147, DS20080148, DS20080149, DS20080150, DS20080152, DS20080153, DS20080155, DS20080158, DS20080159, DS20080160, DS20080161, DS20080163, DS20080164, DS20080165, DS20080166, DS20080167, DS20080168, DS20080170, DS20080171, DS20080172, DS20080174, DS20080176, DS20080180, DS20080181, DS20080182, DS20080183, DS20080184, DS20080185, DS20080186, DS20080187, DS20080188, DS20080189, DS20080191, DS20080192, DS20080194, DS20080195, DS20080196, DS20080198, DS20080201, DS20080202, DS20080203, DS20080204, DS20080205, DS20080206, DS20080207, DS20080209, DS20080210, DS20080211, DS20080212, DS20080214, DS20080215, DS20080216, DS20080217, DS20080218, DS20080219, DS20080220, DS20080221, DS20080222, DS20080223, DS20080224, DS20080225, DS20080227, DS20080228, DS20080229, DS20080230, DS20080231, DS20080232, DS20080233, DS20080234, DS20080236, DS20080237, DS20080239, DS20080241, DS20080242, DS20080243, DS20080244, DS20080245, DS20080246, DS20080249, DS20080250, DS20080252, DS20080253, DS20080254, DS20080255, DS20080256, DS20080258, DS20080259, DS20080260, DS20080261, DS20080262, DS20080263, DS20080264, DS20080265, DS20080266, DS20080268, DS20080269, DS20080270, DS20080271, DS20080273, DS20080275, DS20080276, DS20080278, DS20080279, DS20080280, DS20080281, DS20080282, DS20080283, DS20080284, DS20080285, DS20080286, DS20080287, DS20080289, DS20080291, DS20080292, DS20080298, DS20080299, DS20080300, DS20080303, DS20080304, DS20080306, DS20080307, DS20080308, DS20080309, DS20080310, DS20080312, DS20080313, DS20080318, DS20080320, DS20080321, DS20080322, DS20080323, DS20080325, DS20080326, DS20080327, DS20080328, DS20080330, DS20080331, DS20080333, DS20080334, DS20080335, DS20080336, DS20080337, DS20080338, DS20080341, DS20080342, DS20080343, DS20080346, DS20080348, DS20080349, DS20080356, DS20080357, DS20080358, DS20080361, DS20080362, DS20080363, DS20080364, DS20080365, DS20080368, DS20080370, DS20080373, DS20090001, DS20090002, DS20090003, DS20090004, DS20090005, DS20090006, DS20090007, DS20090008, DS20090009, DS20090011, DS20090013, DS20090014, DS20090015, DS20090016, DS20090017, DS20090020, DS20090021, DS20090024, DS20090026, DS20090027, DS20090029, DS20090031, DS20090032, DS20090033, DS20090034, DS20090035, DS20090037, DS20090039, DS20090042, DS20090043, DS20090045, DS20090046, DS20090048, DS20090051, DS20090052, DS20090054, DS20090057, DS20090058, DS20090059, DS20090063, DS20090064, DS20090065, DS20090066, DS20090068, DS20090069, DS20090071, DS20090072, DS20090073, DS20090074, DS20090076, DS20090077, DS20090080, DS20090082, DS20090084, DS20090085, DS20090086, DS20090088, DS20090089, DS20090090, DS20090091, DS20090092, DS20090093, DS20090094, DS20090095, DS20090096, DS20090097, DS20090098, DS20090099, DS20090100, DS20090101, DS20090102, DS20090103, DS20090104, DS20090105, DS20090106, DS20090107, DS20090108, DS20090110, DS20090112, DS20090113, DS20090114, DS20090116, DS20090118, DS20090119, DS20090121, DS20090122, DS20090123, DS20090124, DS20090125, DS20090127, DS20090128, DS20090129, DS20090130, DS20090132, DS20090133, DS20090134, DS20090135, DS20090136, DS20090137, DS20090138, DS20090139, DS20090141, DS20090142, DS20090144, DS20090145, DS20090146, DS20090147, DS20090149, DS20090150, DS20090151, DS20090152, DS20090153, DS20090156, DS20090157, DS20090158, DS20090159, DS20090160, DS20090161, DS20090162, DS20090164, DS20090165, DS20090166, DS20090168, DS20090169, DS20090170, DS20090171, DS20090172, DS20090173, DS20090174, DS20090175, DS20090176, DS20090177, DS20090178, DS20090179, DS20090180, DS20090181, DS20090182, DS20090183, DS20090185, DS20090189, DS20090190, DS20090191, DS20090192, DS20090193, DS20090196, DS20090197, DS20090198, DS20090200, DS20090201, DS20090202, DS20090203, DS20090204, DS20090205, DS20090206, DS20090207, DS20090208, DS20090209, DS20090210, DS20090211, DS20090212, DS20090213, DS20090214, DS20090215, DS20090216, DS20090218, DS20090219, DS20090220, DS20090221, DS20090222, DS20090223, DS20090224, DS20090225, DS20090226, DS20090227, DS20090230, DS20090231, DS20090232, DS20090233, DS20090235, DS20090236, DS20090238, DS20090239, DS20090240, DS20090242, DS20090243, DS20090244, DS20090245, DS20090247, DS20090248, DS20090249, DS20090250, DS20090251, DS20090252, DS20090253, DS20090256, DS20090257, DS20090259, DS20090260, DS20090261, DS20090262, DS20090263, DS20090265, DS20090266, DS20090267, DS20090268, DS20090269, DS20090270, DS20090271, DS20090273, DS20090274, DS20090275, DS20090277, DS20090278, DS20090279, DS20090280, DS20090281, DS20090282, DS20090283, DS20090284, DS20090288, DS20090289, DS20090290, DS20090291, DS20090292, DS20090293, DS20090294, DS20090295, DS20090297, DS20090299, DS20090300, DS20090301, DS20090302, DS20090303, DS20090304, DS20090305, DS20090306, DS20090307, DS20090308, DS20090309, DS20090311, DS20090313, DS20090314, DS20090315, DS20090316, DS20090318, DS20090319, DS20090320, DS20090321, DS20090322, DS20090323, DS20090324, DS20090326, DS20090327, DS20090332, DS20090333, DS20090334, DS20090335, DS20090336, DS20090338, DS20090341, DS20090343, DS20090344, DS20090345, DS20090346, DS20090347, DS20090348, DS20090349, DS20090351, DS20090353, DS20090354, DS20090356, DS20090357, DS20090358, DS20090359, DS20090360, DS20090361, DS20090362, DS20090365, DS20090367, DS20090369, DS20090371, DS20090372, DS20090373, DS20090375, DS20090380, DS20090381, DS20090383, DS20090386, DS20090387, DS20090388, DS20090390, DS20090392, DS20090393, DS20090394, DS20090396, DS20090397, DS20090401, DS20090402, DS20090404, DS20090405, DS20090407, DS20090408, DS20090409, DS20090410, DS20090411, DS20090414, DS20090417, DS20090418, DS20090420, DS20090422, DS20090428, DS20090430, DS20090431, DS20090432, DS20090434, DS20090435, DS20090436, DS20090437, DS20090438, DS20090439, DS20090444, DS20090445, DS20090448, DS20090453, DS20090455, DS20090459, DS20090461, DS20090462, DS20090465, DS20090466, DS20090468, DS20090469, DS20090470, DS20090472, DS20090474, DS20090479, DS20090480, DS20090483, DS20090484, DS20090487, DS20090488, DS20090492, DS20090493, DS20090495, DS20090496, DS20090498, DS20090499, DS20090500, DS20090501, DS20090502, DS20090504, DS20090505, DS20090506, DS20090507, DS20090508, DS20090509, DS20090511, DS20090512, DS20090513, DS20090516, DS20090517, DS20090518, DS20090520, DS20090523, DS20090524, DS20090525, DS20090526, DS20090527, DS20090531, DS20090532, DS20090533, DS20090534, DS20090536, DS20090538, DS20090539, DS20090540, DS20090541, DS20090542, DS20090543, DS20090544, DS20090545, DS20090546, DS20090549, DS20090550, DS20090553, DS20090554, DS20090555, DS20090556, DS20090557, DS20090558, DS20090560, DS20090561, DS20090562, DS20090563, DS20090564, DS20090565, DS20090566, DS20090567, DS20090569, DS20090570, DS20090571, DS20090573, DS20090574, DS20090575, DS20090576, DS20090578, DS20090580, DS20090582, DS20090583, DS20090584, DS20090585, DS20090586, DS20090587, DS20090588, DS20090589, DS20090590, DS20090591, DS20090592, DS20090593, DS20090594, DS20090595, DS20090596, DS20090597, DS20090598, DS20090600, DS20090601, DS20090602, DS20090603, DS20090604, DS20090605, DS20090606, DS20090607, DS20090608, DS20090609, DS20090610, DS20090611, DS20090612, DS20090614, DS20090615, DS20090616, DS20090617, DS20090618, DS20090619, DS20090620, DS20090622, DS20090623, DS20090624, DS20090625, DS20090626, DS20090627, DS20090629, DS20090630, DS20090631, DS20090632, DS20090633, DS20090634, DS20090635, DS20090636, DS20090637, DS20090639, DS20090640, DS20090641, DS20090642, DS20090643, DS20090644, DS20090645, DS20090646, DS20090647, DS20090648, DS20090649, DS20090650, DS20090651, DS20090653, DS20090654, DS20090655, DS20090656, DS20090658, DS20090659, DS20090660, DS20090661, DS20090662, DS20090664, DS20090665, DS20090666, DS20090667, DS20090668, DS20090669, DS20090670, DS20090671, DS20090672, DS20090673, DS20090674, DS20090675, DS20090676, DS20090678, DS20090679, DS20090680, DS20090681, DS20090682, DS20090683, DS20090684, DS20090685, DS20090686, DS20090687, DS20090689, DS20090690, DS20090691, DS20090692, DS20090693, DS20090694, DS20090695, DS20090696, DS20090697, DS20090698, DS20090699, DS20090700, DS20090701, DS20090702, DS20090703, DS20090704, DS20090705, DS20090706, DS20090707, DS20090708, DS20090709, DS20090710, DS20090711, DS20090712, DS20090713, DS20090714, DS20090715, DS20090716, DS20090717, DS20090718, DS20090719, DS20090720, DS20090721, DS20090722, DS20090723, DS20090724, DS20090725, DS20090726, DS20090727, DS20090729, DS20090730, DS20090731, DS20090732, DS20090733, DS20090734, DS20090735, DS20090736, DS20090737, DS20090739, DS20090740, DS20090741, DS20090742, DS20090744, DS20090745, DS20090746, DS20090747, DS20090748, DS20090749, DS20090750, DS20090751, DS20090752, DS20090753, DS20090754, DS20090755, DS20090756, DS20090757, DS20090758, DS20090759, DS20090760, DS20090761, DS20090762, DS20090763, DS20090764, DS20090765, DS20090766, DS20090767, DS20090768, DS20090769, DS20090770, DS20090771, DS20090772, DS20090773, DS20090774, DS20090775, DS20090776, DS20090777, DS20090778, DS20090779, DS20090780, DS20090781, DS20090783, DS20090784, DS20090785, DS20090786, DS20090787, DS20090788, DS20090789, DS20090790, DS20090792, DS20090795, DS20090796, DS20090798, DS20090799, DS20090800, DS20090801, DS20090802, DS20090804, DS20090805, DS20090807, DS20090808, DS20090809, DS20090810, DS20090811, DS20090812, DS20090814, DS20090816, DS20090817, DS20090818, DS20090819, DS20090820, DS20090821, DS20090824, DS20090825, DS20090827, DS20090828, DS20090829, DS20090832, DS20090833, DS20090834, DS20090835, DS20090836, DS20090837, DS20090838, DS20090839, DS20090840, DS20090843, DS20090844, DS20090845, DS20090846, DS20090847, DS20090848, DS20090849, DS20090850, DS20090851, DS20090852, DS20090854, DS20090855, DS20090857, DS20090858, DS20090859, DS20090860, DS20090861, DS20090862, DS20090863, DS20090864, DS20090865, DS20090866, DS20090867, DS20090868, DS20090869, DS20090870, DS20090871, DS20090872, DS20090873, DS20090874, DS20090875, DS20090876, DS20090877, DS20090878, DS20090879, DS20090880, DS20090881, DS20090882, DS20090883, DS20090885, DS20090886, DS20090887, DS20090888, DS20090890, DS20090891, DS20090892, DS20090893, DS20090894, DS20090896, DS20090897, DS20090898, DS20090899, DS20090900, DS20090901, DS20090902, DS20090903, DS20090904, DS20090905, DS20090906, DS20090907, DS20090908, DS20090909, DS20090910, DS20090911, DS20090912, DS20090913, DS20090914, DS20090915, DS20090916, DS20090917, DS20090918, DS20090919, DS20090920, DS20090921, DS20090922, DS20090924, DS20090925, DS20090926, DS20090927, DS20090928, DS20090929, DS20090931, DS20090932, DS20090933, DS20090934, DS20090935, DS20090936, DS20090937, DS20090938, DS20090939, DS20090940, DS20090941, DS20090942, DS20090943, DS20090944, DS20090945, DS20090946, DS20100001, DS20100002, DS20100003, DS20100004, DS20100005, DS20100006, DS20100007, DS20100008, DS20100009, DS20100010, DS20100011, DS20100013, DS20100014, DS20100015, DS20100016, DS20100017, DS20100019, DS20100020, DS20100021, DS20100022, DS20100023, DS20100024, DS20100025, DS20100026, DS20100027, DS20100028, DS20100029, DS20100030, DS20100031, DS20100032, DS20100033, DS20100034, DS20100035, DS20100036, DS20100037, DS20100038, DS20100039, DS20100040, DS20100041, DS20100042, DS20100043, DS20100044, DS20100046, DS20100048, DS20100049, DS20100050, DS20100051, DS20100055, DS20100056, DS20100057, DS20100058, DS20100059, DS20100060, DS20100061, DS20100062, DS20100063, DS20100065, DS20100066, DS20100068, DS20100069, DS20100070, DS20100072, DS20100073, DS20100074, DS20100075, DS20100076, DS20100077, DS20100078, DS20100079, DS20100080, DS20100081, DS20100082, DS20100083, DS20100084, DS20100085, DS20100086, DS20100087, DS20100089, DS20100090, DS20100091, DS20100092, DS20100094, DS20100095, DS20100097, DS20100098, DS20100099, DS20100100, DS20100102, DS20100104, DS20100105, DS20100106, DS20100107, DS20100108, DS20100109, DS20100112, DS20100114, DS20100115, DS20100116, DS20100117, DS20100118, DS20100119, DS20100120, DS20100122, DS20100123, DS20100125, DS20100126, DS20100127, DS20100128, DS20100129, DS20100130, DS20100131, DS20100132, DS20100134, DS20100135, DS20100136, DS20100137, DS20100138, DS20100140, DS20100141, DS20100142, DS20100143, DS20100144, DS20100146, DS20100147, DS20100148, DS20100150, DS20100151, DS20100153, DS20100154, DS20100155, DS20100156, DS20100158, DS20100159, DS20100160, DS20100161, DS20100162, DS20100163, DS20100164, DS20100165, DS20100166, DS20100167, DS20100168, DS20100169, DS20100170, DS20100171, DS20100172, DS20100174, DS20100176, DS20100177, DS20100178, DS20100180, DS20100181, DS20100182, DS20100183, DS20100184, DS20100185, DS20100186, DS20100187, DS20100188, DS20100191, DS20100193, DS20100194, DS20100195, DS20100196, DS20100197, DS20100198, DS20100199, DS20100200, DS20100201, DS20100204, DS20100206, DS20100207, DS20100208, DS20100209, DS20100210, DS20100211, DS20100212, DS20100213, DS20100214, DS20100216, DS20100217, DS20100218, DS20100221, DS20100223, DS20100224, DS20100225, DS20100226, DS20100227, DS20100228, DS20100229, DS20100230, DS20100231, DS20100232, DS20100233, DS20100234, DS20100235, DS20100236, DS20100237, DS20100238, DS20100239, DS20100240, DS20100241, DS20100242, DS20100243, DS20100244, DS20100245, DS20100246, DS20100248, DS20100249, DS20100250, DS20100251, DS20100252, DS20100253, DS20100254, DS20100255, DS20100256, DS20100257, DS20100258, DS20100259, DS20100260, DS20100262, DS20100263, DS20100264, DS20100265, DS20100266, DS20100267, DS20100268, DS20100269, DS20100270, DS20100271, DS20100272, DS20100273, DS20100274, DS20100275, DS20100276, DS20100278, DS20100279, DS20100280, DS20100281, DS20100282, DS20100283, DS20100284, DS20100285, DS20100286, DS20100287, DS20100288, DS20100289, DS20100290, DS20100291, DS20100292, DS20100293, DS20100294, DS20100295, DS20100297, DS20100298, DS20100299, DS20100300, DS20100301, DS20100302, DS20100303, DS20100304, DS20100305, DS20100306, DS20100307, DS20100308, DS20100309, DS20100311, DS20100312, DS20100314, DS20100316, DS20100317, DS20100318, DS20100319, DS20100322, DS20100323, DS20100324, DS20100326, DS20100327, DS20100328, DS20100329, DS20100331, DS20100332, DS20100333, DS20100335, DS20100336, DS20100337, DS20100339, DS20100340, DS20100341, DS20100342, DS20100343, DS20100344, DS20100345, DS20100346, DS20100347, DS20100349, DS20100350, DS20100351, DS20100352, DS20100355, DS20100358, DS20100359, DS20100360, DS20100362, DS20100363, DS20100365, DS20100366, DS20100368, DS20100370, DS20100372, DS20100374, DS20100375, DS20100376, DS20100377, DS20100378, DS20100379, DS20100380, DS20100381, DS20100382, DS20100383, DS20100384, DS20100385, DS20100386, DS20100387, DS20100389, DS20100390, DS20100391, DS20100392, DS20100393, DS20100394, DS20100396, DS20100397, DS20100398, DS20100399, DS20100400, DS20100401, DS20100405, DS20100406, DS20100407, DS20100408, DS20100409, DS20100411, DS20100412, DS20100413, DS20100414, DS20100415, DS20100416, DS20100417, DS20100418, DS20100419, DS20100420, DS20100421, DS20100424, DS20100425, DS20100427, DS20100429, DS20100430, DS20100432, DS20100433, DS20100434, DS20100435, DS20100436, DS20100437, DS20100438, DS20100439, DS20100440, DS20100441, DS20100442, DS20100443, DS20100444, DS20100445, DS20100446, DS20100448, DS20100449, DS20100451, DS20100452, DS20100453, DS20100455, DS20100456, DS20100457, DS20100458, DS20100459, DS20100460, DS20100461, DS20100462, DS20100463, DS20100464, DS20100465, DS20100466, DS20100467, DS20100468, DS20100470, DS20100471, DS20100472, DS20100475, DS20100476, DS20100478, DS20100479, DS20100480, DS20100481, DS20100482, DS20100483, DS20100485, DS20100486, DS20100487, DS20100488, DS20100490, DS20100491, DS20100492, DS20100494, DS20100496, DS20100497, DS20100498, DS20100499, DS20100500, DS20100501, DS20100502, DS20100503, DS20100504, DS20100505, DS20100506, DS20100507, DS20100511, DS20100515, DS20100516, DS20100517, DS20100518, DS20100519, DS20100520, DS20100521, DS20100523, DS20100524, DS20100525, DS20100526, DS20100527, DS20100528, DS20100529, DS20100530, DS20100531, DS20100532, DS20100533, DS20100534, DS20100535, DS20100536, DS20100537, DS20100538, DS20100539, DS20100540, DS20100541, DS20100542, DS20100543, DS20100544, DS20100545, DS20100547, DS20100549, DS20100550, DS20100551, DS20100553, DS20100556, DS20100557, DS20100560, DS20100561, DS20100562, DS20100563, DS20100564, DS20100565, DS20100566, DS20100567, DS20100568, DS20100570, DS20100571, DS20100572, DS20100573, DS20100574, DS20100575, DS20100581, DS20100582, DS20100584, DS20100585, DS20100586, DS20100587, DS20100589, DS20100590, DS20100592, DS20100593, DS20100594, DS20100595, DS20100596, DS20100597, DS20100598, DS20100600, DS20100603, DS20100605, DS20100606, DS20100610, DS20100616, DS20100617, DS20100622, DS20100624, DS20100626, DS20100629, DS20100630, DS20100632, DS20100633, DS20100636, DS20100637, DS20100638, DS20100639, DS20100641, DS20100642, DS20100643, DS20100644, DS20100645, DS20100646, DS20100648, DS20100649, DS20100650, DS20100651, DS20100652, DS20100653, DS20100654, DS20100655, DS20100656, DS20100657, DS20100658, DS20100660, DS20100661, DS20100662, DS20100663, DS20100664, DS20100666, DS20100669, DS20100673, DS20100674, DS20100676, DS20100678, DS20100679, DS20100680, DS20100681, DS20100685, DS20100687, DS20100688, DS20100689, DS20100690, DS20100691, DS20100692, DS20100696, DS20100699, DS20100700, DS20100701, DS20100703, DS20100704, DS20100705, DS20100706, DS20100707, DS20100708, DS20100709, DS20100710, DS20100711, DS20100713, DS20100715, DS20100717, DS20100718, DS20100720, DS20100722, DS20100723, DS20100724, DS20100725, DS20100728, DS20100730, DS20100734, DS20100735, DS20100736, DS20100737, DS20100738, DS20100739, DS20100740, DS20100741, DS20100742, DS20100743, DS20100744, DS20100745, DS20100751, DS20100752, DS20100753, DS20100756, DS20100759, DS20100768, DS20100771, DS20100773, DS20100774, DS20100776, DS20100777, DS20100780, DS20100782, DS20100783, DS20100784, DS20100793, DS20100798, DS20100800, DS20100803, DS20100806, DS20100807, DS20100816, DS20100830, DS20100837, and DS20100931
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ikaria Holdings, Clinton, NJ, .
Manufacturer: INO Therapeutics, Middleton, WI. 
REASON
The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients.
VOLUME OF PRODUCT IN COMMERCE
2,507 units
DISTRIBUTION
Nationwide and Countries of Canada and Malaysia

PRODUCT
1) Engage" TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. 

2) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. 

3) Engage" TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. 

4) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. 

5) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564. CODE
1) Batch: 3109782;

2) Batch: 3105838;

3) Batch in US and OUS: 310764;

4) Batches in US: 3103891, 3110889, 3110892, 3118794, 3123051. Batches OUS: 3110892, 3118797;

5) Batches: 3107789, 3107790
RECALLING FIRM/MANUFACTURER
St. Jude Medical Cardiovascular Division, Minnetonka, MN, .
REASON
St Jude Medical Cardiovascular Division is performing a voluntary recall of certain batches of the 6 Fr. Engage" Introducer produced during the time period of 27 April to 03 June 2010. They have identified that a very small percentage of devices in the affected batches have the potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief. To date, no adverse events related to this issue have been reported.
VOLUME OF PRODUCT IN COMMERCE
5,120 units
DISTRIBUTION
OK, MN, CA, AZ, IN, SC, ME, MS, AR, NY, WY, NH, NJ, IL, VA, TX, UT, CT, LA, NM, PA, HI, AR, MI, WA, MO, NV, TN, KS, KY, OH, CO, WI, FL, and Countries of Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia

PRODUCT MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.  Model/Catalog Numbers: 800-01-368/370; 800-02-343/345; Specials that are affected: S1028, S1046, S1130, S1135, S1305, S1366, S1373, S1374, S1375, S1403, S1468, S1469, S1470, S1511, S1512, S1513. CODE Model and Catalog numbers only,
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, 
REASON A crack or complete fracture in the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks.
VOLUME OF PRODUCT IN COMMERCE
729 and 67 Specials
DISTRIBUTION
Nationwide and Internationally

PRODUCT IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Micro particles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; list 5C91-21. The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy. 
CODE
Lot number 802873106, Expiry Date May13, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, 
Manufacturer: Axis-Shield Diagnostics, Ltd., Dundee, UK. 
REASON IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
VOLUME OF PRODUCT IN COMMERCE
466 (207 kits Nationwide; 259 kits internationally)
DISTRIBUTION
Nationwide and Internationally

PRODUCT Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; list 01L76-25. The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy. 
CODE
Lot 80162M100, Expiry Date May 03, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, .
Manufacturer: Fujirebio Diagnostics, Inc., Malvern, PA. 
REASON The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.
VOLUME OF PRODUCT IN COMMERCE
875 kits
DISTRIBUTION
Nationwide and Internationally

PRODUCT Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. 
CODE
Lot numbers FQT09K07A through FQT10F09A
RECALLING FIRM/MANUFACTURER
Spectranetics Corp., Colorado Springs, CO,
REASON
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
VOLUME OF PRODUCT IN COMMERCE
5,080 units
DISTRIBUTION
Nationwide and Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela

PRODUCT SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart. Part number P05813 and P06841. 
CODE
Serial numbers: DOMESTIC: 03B3G4, 03B7BJ, 03BKK9, 03CWKJ, 037XL6, 034J4X, 034T2R, 038fdn, 03BKJH, 03B3FT, 039F3H, 03BC26, 03CJTD, 03CHVH, 039F3L, 034Z4M, 03CWKD, 0354HB, 039F3J, 039F3Q, 03B3G3, 0354HC, 03B7B3, 0354HD, 03BKJ0, 03BKJK, 0356LC, 0360X5, 03BC2B, 03CVVH, 03CCBT, 0377LT, 038WXY, 03BC25, 037MR9, 037XPX, 03B3FY, 037XQ1, 03B3FX, 0392RC, 03B3G0, 0356FB, 035G72, 035NT0, 038WTJ, 03BKJF, 038WY1, 038WY3, 038WY5, 03CHVG, 03B3FW, 03CJ7D, 0392R8, 03CHVM, 03B3FV, 03936X, 0361FF, 0354J0, 0377LQ, 03CWCX, 0379T3, 037F5D, 03BC2G, 037X7R, 035NT3, 0384GM, 0392LP, 0360X7, 0376PB, 03936W, and 03BKKC. INTERNATIONAL: 035G71, 038FDP, 039V7L, 0356C3, 037XQ5, 0384K6, 0392RH, 03CJ83, 0377LN, 0392RG, 039KD3, 039V7P, 039V7T, 03BC24, 03BC2D, 03BKJJ, 03BKKY, 038WRH, 03CCBQ, 0384FH, 039KD4, 03BC20, 034PGZ, 034PH0, 03CCBR, 03BC23, 03CWKL, 034T2T , 03B7B2, 0384FL, 0384GN, 0384K4, 0384K5, 038WRD, 0390MH, 039190, 03918Z, 03BKKW, 03CJ82, 03CJ7B, 03CJ81, 03CJ86, 03CJ87, 03CJ88, 037XL7, 0384BX, 038WY7, 034PGQ, 0392RL, 034PGV, 03BC2C, 0392R9 , 039196 ,03CHVF, 03CJTB, 03CJTC, 034T30, 03570P, 0354HF, 0377LP, 038FL4 , 03CCBP, 03CWKF, 037MR7, 037XPW, 037MR6, 0384FJ, 034TN9, 0356HM, 038WTM, 0356GL, 034T32 , 039198, 0360YT , 0384CZ, 0384D1, 0361G5, 03B7B2, 03BKJG, 03CHVD, 03CJ7C, 03CJ84, 03CJ8B, 03CVVJ, 034T2W , 0356BV , 0377LV, 037MRC, 038WRJ, 039F3R, 0361DN, 036GYG, 037LTV, 037MR8, 037XQ3, 034PGX 035TZK, 034P7Y, 034PGM, 034PGP, 0356BW, 035G9X, 035NT2, 0361G6, 036GYD, 037F1Y, 037LTQ, 037LTT, 037LTY, 037M8T, 037XPY, 038WY2, 039V7M, 03CWD1, 03CWKM, 038XKX, 034NMJ, 0356C2, 034T2V, 034T2X, 034TNW, 034TNZ, 0354H9, 0356LD, 0360YV, 037XL8, and 0390MC
RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA,

REASON The TEE transesophageal transducer, when connected to a Sonosite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.
VOLUME OF PRODUCT IN COMMERCE
357 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. Made in USA. The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy. 
CODE
Lot 0904151 through 1005201
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linvatec Corp., dba ConMed Linvatec, Largo, FL,
Manufacturer: ConMed Corp., Utica, NY. 
REASON
Product may have a breach in the seal that could potentially compromise the sterility of the contents.
VOLUME OF PRODUCT IN COMMERCE
97,830 sets
DISTRIBUTION
Nationwide and Canada

PRODUCT Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy
Jose Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its electrosurgical probe. Examples of use include resection, ablation and coagulation of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints. The probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants. 
CODE Manufactured between June 2009 and April 2010. All serial numbers are affected.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, 
REASON
RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
VOLUME OF PRODUCT IN COMMERCE
989 units
DISTRIBUTION
Nationwide and Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EME

PRODUCT Dynasty A-Class Poly Liner, REF DLXP-LD36, 1 each, Rx only, Sterile EO, Group D, I.D. 36 mm, LIP 15o, Liner STD. Product is used in total hip arthroplasty. 
CODE Lot number: 0501136375
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN,.
REASON
The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION
WI, WV, IN, IA, GA

PRODUCT DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope. 
CODE A lot number listing is not applicable as this is a field correction of the labeling. The 0109 hookup itself is not defective and can still be used safely with other endoscopes.
RECALLING FIRM/MANUFACTURER
Minntech, Corp., Plymouth, MN, 
REASON The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinted DSD hook up Application Guide (M04-0001 revision M).
VOLUME OF PRODUCT IN COMMERCE 185 units
DISTRIBUTION
Nationwide

PRODUCT Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems. CODE
Lot Numbers: 911158, 911581, and 917631
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, 
REASON The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established reference range, but are elevated and statistically different than results from an uncontaminated control lot. Elevated CV's may also be observed with the contaminated vials.
VOLUME OF PRODUCT IN COMMERCE
166 units
DISTRIBUTION
Nationwide and Canada

WEEK ENDING AUGUST 14

Ikaria® Recalls INOMAX® DS Drug-Delivery System 

Ikaria, Inc. is recalling its INOMAX® DS drug-delivery systems due to the potential failure of a pressure switch which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients. 

Ikaria has already begun the replacement process of all INOMAX DS drug-delivery systems with remediated INOMAX DS systems. 

Customers with questions regarding this notice may contact Ikaria Customer Care at 1¬877-KNOW-INO (1-877-566-9466) for assistance. 

WEEK ENDING AUGUST 7