Medical Device Recalls

ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0

Synovo Production

PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

Biomerieux Inc

Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941

Covidien

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Smith & Nephew, Inc.

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

B Braun Medical Inc

Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile

Baxter Healthcare Corporation

The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, effici

Trimble Ab

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number

B. Braun Medical, Inc.

dS Breast 7ch 1.5T

Philips North America Llc

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

SML Distribution, LLC

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS68

MEDLINE INDUSTRIES, LP - Northfield

IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159

Medicrea International

TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

Howmedica Osteonics Corp.

Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILIC

MEDLINE INDUSTRIES, LP - Northfield

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116)

GE Healthcare, LLC

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02

DeRoyal Industries Inc

Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing

Steris Corporation

Endovascular AAA Pack, ESED52B; Medical convenience kit

American Contract Systems, Inc.

Injection Needle, REF: 25207

Karl Storz Endoscopy

Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

MEDLINE INDUSTRIES, LP - Northfield

eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

Civco Medical Instruments Co. Inc.

Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ4411

MEDLINE INDUSTRIES, LP - Northfield

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL

Acumed LLC

2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB

American Contract Systems Inc

KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent

King Systems Corp. dba Ambu, Inc.

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Terumo Cardiovascular Systems Corporation

CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022

Carefusion 2200 Inc