Medical Device Recalls

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

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.

O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000

MEDLINE INDUSTRIES, LP - Northfield

Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

SEASPINE ORTHOPEDICS CORPORATION

a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylc

Mckesson Medical-Surgical Inc. Corporate Office

McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

Cypress Medical Products LLC

Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of

Edwards Lifesciences, LLC

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06

Linkbio Corp.

DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

Beckman Coulter, Inc.

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients

Fresenius Kabi USA, LLC

Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pa

MEDLINE INDUSTRIES, LP - Northfield

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

PFM MEDICAL INC.

CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to conta

The Metrix Company

Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP

MEDLINE INDUSTRIES, LP - Northfield

LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

CORENTEC CO., LTD

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

ICU Medical, Inc.

Surgical Suture Kit

Stradis Healthcare

Allura Xper FD20/10; System Code: 722029;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13

DeRoyal Industries Inc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter

Boston Scientific Corporation

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07

Linkbio Corp.