FDA Device Recalls

Class IITerminated

Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

Haemonetics Corporation

When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

April 19, 2022 · Device

Effluent Sample Bag

LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

Turbett Surgical Container, TS1500

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

XVIVO Organ Chamber REF 19020

TMJ Arthroscopy Drape, 85''x 96''

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument