Medical Device Recalls

ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.

Mckesson Medical-Surgical Inc. Corporate Office

GEM Premier 5000 PAK; Part No. 00055415004.

Instrumentation Laboratory

Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYN

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 So

B Braun Medical Inc

regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit

ROi CPS LLC

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE

Cordis US Corp

Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Sma

Intuitive Surgical, Inc.

Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Pr

Alcon Research LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000195;

Beaver Visitec International, Inc.

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

Diasol, Inc

VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR

Sterilmed, Inc.

DeRoyal SHOULDER KIT, REF 89-9497.10

DeRoyal Industries Inc

Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15

Philips Respironics, Inc.

eSuction Small Cavity, Model ET2005

Endo-Therapeutics, Inc.

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055

TELEFLEX LLC

activforce 2 package labeling: Model: Activ5-M R 201-200563

Activbody, Inc.

Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178

Datascope Corp.

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PRO

Medline Industries, LP

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-7

ConMed Corporation

PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586

Biomerieux Inc

Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software

Draeger, Inc.

ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pac

ConMed Corporation

Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syrin

Jiangsu Shenli Medical Production Co., Ltd.

Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal

Olympus Corporation of the Americas

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Medline Industries, LP

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization

Medtronic Sofamor Danek USA Inc

Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC