Medical Device Recalls

STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59

Diagnostica Stago, Inc.

COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N

Cook Incorporated

CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128

Carefusion 2200 Inc

Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , P

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mo

Tyber Medical

Trumpet, Needle Guide, Cat# TMS-200

Technicality Inc.

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

B Braun Medical Inc

PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

Universal Meditech Inc.

KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards

Straumann USA LLC

SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the

Datascope Corp.

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

BioFire Diagnostics, LLC

Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

Avanos Medical, Inc.

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina

GE Medical Systems, LLC

CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary

St. Jude Medical

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Resource Optimization & Innovation LLC

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Bio-Rad Laboratories, Inc.

EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duo

Boston Scientific Corporation

CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 i

MEDLINE INDUSTRIES, LP - Northfield

8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

Intuitive Surgical, Inc.

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322

Biomet, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Numbe

MEDLINE INDUSTRIES, LP - Northfield

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

Covidien

McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

CHANGE HEALTHCARE CANADA COMPANY

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525

TELEFLEX LLC

HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072

Stradis Medical, LLC dba Stradis Healthcare

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Disc

GE Healthcare (China) Co., Ltd.

ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 38

Contract Medical International GmbH

Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during

B Braun Medical Inc