Medical Device Recalls

DeRoyal KIT EXTREMITY PACK, REF 89-8869.09

DeRoyal Industries Inc

Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005

Stryker Corporation

Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08

AVID Medical, Inc.

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Mazor Robotics Ltd

SmartPath to dStream for 3.0T, Model Number: 782145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Synapse PACS - Version 7.1.000

FUJIFILM Healthcare Americas Corporation

BiPAP V30 Auto Ventilator, Part Number 1111178

Philips Respironics, Inc.

Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155

Covidien, LP

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180

C.R. Bard Inc

Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's

Clark Laboratories, Inc.

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem

Biomerieux Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, M

MEDLINE INDUSTRIES, LP - Northfield

ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

Biomerieux Inc

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B

Medline Industries, LP

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS

Stryker Corporation

Spectral CT; Product Code (REF): 728333;

Philips North America Llc

HAMILTON-C6, REF: 160021

Hamilton Medical AG

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i

Fresenius Kabi USA, LLC

Burlington Medical, Leg Wraps.

Burlington Medical, LLC

Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

Stryker Corporation

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc.

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Becton, Dickinson and Company

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W;

MEDLINE INDUSTRIES, LP - Northfield

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08

Cook Incorporated

Various Angiography packs/trays

American Contract Systems, Inc.

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl

Beckman Coulter Inc.

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03

DeRoyal Industries Inc

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medlin

Medline Industries, LP

A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal

Tyber Medical

Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TR

MEDLINE INDUSTRIES, LP - Northfield