Medical Device Recalls

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

DEPUY (IRELAND)

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distra

Baxter Healthcare Corporation

Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)

Invacare Corporation

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Aesculap AG

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Componen

Draeger Medical, Inc.

WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Numb

Wishbone Medical, Inc.

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this reca

Envisiontec US Llc

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065.

Beckman Coulter Inc.

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

Paragonix Technologies Inc.

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus a

Microbiologics Inc

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

Masimo Corporation

Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Stryker GmbH

FIRST RESPONSE 2 CT, SKU 902343

Family Dollar Stores, Llc.

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

B Braun Medical Inc

Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

Windstone Medical Packaging, Inc.

Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519

Baxter Healthcare Corporation

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

Medtronic Inc

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-E

Northeast Scientific Inc.

Alaris PCA Module 8120

CareFusion 303, Inc.

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Intuitive Surgical, Inc.

CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

Baxter Healthcare Corporation

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump

Smiths Medical ASD Inc.

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model

Medline Industries, LP

Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

LEICA BIOSYSTEMS NUSSLOCH GMBH

Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3

B. Braun Medical, Inc.

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Medartis Inc.

Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-d

Karl Storz Endoscopy

ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC32

MEDLINE INDUSTRIES, LP - Northfield