Medical Device Recalls

CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators

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

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11

Merit Medical Systems, Inc.

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psor

Daavlin Distributing Company

UROSKOP Omnia Max. Model Number: 10762473

Siemens Medical Solutions USA, Inc

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number:

Cardinal Health 200, LLC

Synapse PACS - Version 7.1.000US

FUJIFILM Healthcare Americas Corporation

Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s

Philips Respironics, Inc.

DeRoyal CUSTOM NEURO PACK, REF 89-7353.17

DeRoyal Industries Inc

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223

Cardinal Health 200, LLC

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Baxter Healthcare Corporation

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On

MICROVENTION INC.

UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:

Howmedica Osteonics Corp.

Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

DAYE (ANNE'S DAY LTD)

MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A

MEDLINE INDUSTRIES, LP - Northfield

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

Getinge Usa Sales Inc

Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgica

Carefusion 2200 Inc

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Invacare Corporation

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

B Braun Medical Inc

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

ICU Medical, Inc.

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14

DeRoyal Industries Inc

FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

BioFire Diagnostics, LLC

Philips V6-2 Transducer.

Philips Ultrasound, Inc

2008T Hemodialysis SYS, with CDX

Fresenius Medical Care Holdings, Inc.

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: S

ARROW INTERNATIONAL, LLC

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El

Elekta, Inc.

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

ROi CPS LLC

Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Descript

Dentsply IH, Inc.

Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

Cardinal Health 200, LLC

C315-HIS Delivery Catheter

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

Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A

Waismed Ltd.