Medical Device Recalls

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E

Baxter Healthcare Corporation

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

B Braun Medical Inc

Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

Baxter Healthcare Corporation

Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Ve

MEDLINE INDUSTRIES, LP - Northfield

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen

CareFusion 303, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T

MEDLINE INDUSTRIES, LP - Northfield

EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a

Olympus Corporation of the Americas

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut

Young Dental Manufacturing I, LLC

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc.

C6-2 Transducer Probe

Philips Ultrasound, Inc

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e

MEDLINE INDUSTRIES, LP - Northfield

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Philips North America Llc

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

GE Medical Systems, LLC

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

Abiomed, Inc.

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX0740

Covidien, LP

COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;

Beaver Visitec International, Inc.

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

Philips North America

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiratio

B. Braun Medical, Inc.

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOM

Medline Industries, LP

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673

Baxter Healthcare Corporation

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m

MICROVENTION INC.

HAND PACK-Procedure Kit Catalog Number: WEHD16B

American Contract Systems Inc

CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators

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

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, RE

CAREFUSION

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

LSL Healthcare Inc.

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Stradis Healthcare