Medical Device Recalls

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement thera

Baxter Healthcare Corporation

Medtronic SynchroMed II, Model 8637-20, Programmable pump

Medtronic Neuromodulation

3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape

3M Healthcare Business

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 AN

Medline Industries, LP

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN):

Siemens Healthcare Diagnostics, Inc.

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Ve

SunMed Holdings, LLC

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

PATH

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHRO

MEDLINE INDUSTRIES, LP - Northfield

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List

Smiths Medical ASD Inc.

Medshape Universal Joints, REF: DNE-9000-UJ

Medshape, INC.

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

DePuy Orthopaedics, Inc.

FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in t

Synthes (USA) Products LLC

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206

ARROW INTERNATIONAL, LLC

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

Boston Scientific Corporation

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

C.R. Bard Inc

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog

Olympus Corporation of the Americas

Everest MI XT Inner Dilator, Catalog Number 5101-90167

K2M, Inc

MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Medtronic MiniMed, Inc.

Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Corin Ltd

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10

Boston Scientific Neuromodulation Corporation

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

Smiths Medical ASD Inc.

URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF

MEDLINE INDUSTRIES, LP - Northfield

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

B Braun Medical Inc

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

IMPRIS Imaging Inc

Colonovideoscope Model CF-H180AL

Olympus Corporation of the Americas

Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3

Copan WASP

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product

Abiomed, Inc.

Pet Allergy Test

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