Medical Device Recalls

LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002

Physio-Control, Inc.

DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250

Mckesson Medical-Surgical Inc. Corporate Office

Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINO

MEDLINE INDUSTRIES, LP - Northfield

LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

Boston Scientific Corporation

DeRoyal GU PACK, REF 89-10665.03

DeRoyal Industries Inc

Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-S

Biomeme, Inc.

DeRoyal BIOPSY PACK, REF 89-9739.05

DeRoyal Industries Inc

ORAcollect RNA: ORE-100

DNA Genotek Inc.

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Ortho-Clinical Diagnostics, Inc.

BLOOD CULTURE KIT, REF DYNDH1647B

MEDLINE INDUSTRIES, LP - Northfield

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Turbett Surgical Container, TS1500

Turbett Surgical, Inc.

Cub Pediatric Crib, Model FL19H

Stryker Medical Division of Stryker Corporation

Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single

Siemens Medical Solutions USA, Inc

Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) A

ev3 Inc

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Philips North America Llc

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

BioPro, Inc.

FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/

Carwild Corporation

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number

Zimmer, Inc.

Veradius Unity, Model #718132

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device

C.R. Bard Inc

DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03

DeRoyal Industries Inc

BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet

CareFusion 303, Inc.

Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (C

ZOLL Circulation, Inc.

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide intern

Bard Access Systems, Inc.

BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

Biomerieux Inc

ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Nerve Block Tray Catalog Number: 6796R3

Busse Hospital Disposables, Inc.

Candida Test

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