Medical Device Recalls

Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY K

Medline Industries, LP

ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

VentStar Anesthesia (N) 180, MP00333

Draeger Medical, Inc.

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

B Braun Medical Inc

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen

Meridian Bioscience Inc

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050

TELEFLEX LLC

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650

Mentor Texas, LP.

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,

Spectranetics Corporation

Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a

Stryker Corporation

Gentueri Viral Transport Medium (VTM), Sterile, IVD

Gentueri Inc

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

ROi CPS LLC

Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P

Medline Industries, LP

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Abbott Laboratories

Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and he

Siemens Healthcare Diagnostics, Inc.

CombiDiagnost R90 1.1 (709031)

PHILIPS MEDICAL SYSTEMS

Philips 3D9-3v Transducer.

Philips Ultrasound, Inc

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

AVID Medical, Inc.

Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

Mirion Technologies (Capintec), Inc.

Sterile Epidural Tray Catalog Number: 6259R2

Busse Hospital Disposables, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: C

Medline Industries, LP

Stryker Blueprint Software, Catalog #BPUE001.

Tornier S.A.S.

OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure

Advanced Instruments, LLC

Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No soft

Tecfen Medical

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

Integra LifeSciences Corp. (NeuroSciences)

Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

Adept Medical Ltd

nordicBrainEX, software versions 2.21 through 2.3.10

NordicNeuroLab AS

Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US

PI CARDIA LTD

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Contamac Solutions, Inc.

VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V

bioMerieux, Inc.