Medical Device Recalls

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Atrium Medical Corporation

Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE

Philips North America LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001467;

Beaver Visitec International, Inc.

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PAC

MEDLINE INDUSTRIES, LP - Northfield

CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF

MEDLINE INDUSTRIES, LP - Northfield

Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216

Mckesson Medical-Surgical Inc. Corporate Office

Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description:

Baxter Healthcare Corporation

a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12B

Mckesson Medical-Surgical Inc. Corporate Office

Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K;

Medline Industries, LP

HENRY SCHEIN, BREAST PACK, Item No.570-2397

Stradis Medical, LLC dba Stradis Healthcare

Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R,

Aesculap Inc

Halyard EP PACK - Medical convenience kits Model Number: VANW018-06

AVID Medical, Inc.

OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-

Exactech, Inc.

Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE AR

MEDLINE INDUSTRIES, LP - Northfield

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an int

Boston Scientific Corporation

DeRoyal CRANI PACK, REF 89-10242.04

DeRoyal Industries Inc

Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B

Philips Respironics, Inc.

Endo-Model Replacement Plateau; Item Number: 15-0027/16;

Waldemar Link GmbH & Co. KG (Mfg Site)

Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

LeMaitre Vascular, Inc.

Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 0081006856885

BALT USA, LLC

Medline convenience kits: PORT A CATH DYNJ906818A

Medline Industries, LP

2008T HD SYS. CDX BLUESTAR

Fresenius Medical Care Holdings, Inc.

NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC

Landauer

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number

Philips North America

Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version

Insulet Corporation

PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG399

Cordis US Corp

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Exp

Baxter Healthcare Corporation

API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

Biomerieux Inc

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX).

Exactech, Inc.