Medical Device Recalls

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro P

Windstone Medical Packaging, Inc.

Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

Smiths Medical ASD Inc.

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

Smiths Medical ASD, Inc.

iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408

Atrium Medical Corporation

RADPRO MOBILE, Mobile X-ray system

SEDECAL SA

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524

Howmedica Osteonics Corp.

SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801

Family Dollar Stores, Llc.

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES

CareFusion 303, Inc.

MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

Medline Industries, LP

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (

Abbott Molecular, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001527;

Beaver Visitec International, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

Howmedica Osteonics Corp.

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

SynCardia Systems LLC

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426;

MEDLINE INDUSTRIES, LP - Northfield

CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001637;

Beaver Visitec International, Inc.

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Myolyn Inc.

Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack

MEDLINE INDUSTRIES, LP - Northfield

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Boston Scientific Corporation

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omn

Agilent Technologies, Inc.

Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLB

W L Gore & Associates, Inc.

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

Cook Incorporated

Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for steriliz

Howmedica Osteonics Corp.

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Crania

Medtronic Navigation, Inc.

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu

GE Medical Systems, LLC

A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for

Tyber Medical