Medical Device Recalls

Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position

Baxter Healthcare Corporation

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814;

Sklar Instruments

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A P

Waismed Ltd.

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

B Braun Medical Inc

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

ICU Medical, Inc.

Akkermansia Test

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Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent

SVS LLC

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

B Braun Medical Inc

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130

Merit Medical Systems, Inc.

See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC

Medline Industries, LP

VL13-5 Transducer Probe

Philips Ultrasound, Inc

Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-

Penner Patient Care, Inc.

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEM

BioPro, Inc.

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F

Edwards Lifesciences, LLC

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Howmedica Osteonics Corp.

Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekt

Elekta, Inc.

MiniMed 740G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

SM_40HF_BDC3, Mobile X-ray system

SEDECAL SA

DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

DeRoyal Industries Inc

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

Covidien Llc

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a pe

Boston Scientific Corporation

MAMMOMAT Inspiration;

Siemens Medical Solutions USA, Inc

ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar

B Braun Medical Inc

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apher

Angiodynamics, Inc.

Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

Abiomed, Inc.

Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version

Medimaps Group

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A

Edwards Lifesciences, LLC

Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615

Corin Ltd

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100

Baxter Healthcare Corporation