Medical Device Recalls

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Caire, Inc.

McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only

Covidien

Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)

Covidien, LP

L11-3 Transducer Probe

Philips Ultrasound, Inc

DeRoyal TOTAL HIP PACK, REF 89-9301.07

DeRoyal Industries Inc

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918

Sklar Instruments

Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

LeMaitre Vascular, Inc.

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

MEDLINE INDUSTRIES, LP - Northfield

LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N

Integrity Implants Inc.

Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM;

Aesculap Implant Systems LLC

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

Zeltiq Aesthetics, Inc

Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model

Siemens Medical Solutions USA, Inc

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Baxter Healthcare Corporation

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and

Siemens Healthcare Diagnostics, Inc.

BlueFIRE Inflation Device, REF: IN10140

Merit Medical Systems, Inc.

V8 Immunodisplacement Kit REF 1803

Helena Laboratories, Corp.

Effluent Sample Bag

Baxter Healthcare Corporation

MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to sec

Mckesson Medical-Surgical Inc. Corporate Office

Thermalon Eye Compress, Item Number 2434

Bruder Healthcare Company, LLC

Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

DAYE (ANNE'S DAY LTD)

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Bio-Rad Laboratories, Inc.

Plum Duo Infusion System, List Number 40002-04-01

ICU Medical, Inc.

LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/

Waldemar Link GmbH & Co. KG (Mfg Site)

Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT

MEDLINE INDUSTRIES, LP - Northfield

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal pa

LTS Therapy Systems, LLC

KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

MEDLINE INDUSTRIES, LP - Northfield

Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

CHANGE HEALTHCARE CANADA COMPANY

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integ

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062

Steris Corporation

CARDIAC ROBOT PACK. Medical convenience kit.

AVID Medical, Inc.