Medical Device Recalls

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;

Beaver Visitec International, Inc.

SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560

Busse Hospital Disposables, Inc.

Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

Cardinal Health 200, LLC

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

C.R. Bard Inc

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), R

Medtronic Neuromodulation

Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of t

Roche Diagnostics Operations, Inc.

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

Smiths Medical ASD Inc.

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPP

Medline Industries, LP

Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set us

BD SWITZERLAND SARL

7.5MHZ Endo Transducer Probe

Philips Ultrasound, Inc

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

Bivona Aire-Cuf Endotracheal Tube

Smiths Medical ASD Inc.

LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

CooperSurgical, Inc.

ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G

Siemens Medical Solutions USA, Inc.

Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and f

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3

Carefusion 2200 Inc

Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74

Baxter Healthcare Corporation

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314

Biomet, Inc.

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Mod

Siemens Medical Solutions USA, Inc

HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with adva

Heartware, Inc.

PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P

Permobil

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A

Edwards Lifesciences, LLC

Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other

Ion Beam Applications S.A.

StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-pati

Nova Biomedical Corporation

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS

MEDLINE INDUSTRIES, LP - Northfield

Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS

ARROW INTERNATIONAL, LLC

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA

Maquet Medical Systems USA

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

Biomerieux Inc

Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK

Covidien, LP

SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimul

LivaNova USA, Inc.