AVID Medical, Inc.: Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

Hazard

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

Details from the source

Reason for recall: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions Distribution: US Nationwide distribution. Quantity: 33 eaches Lot/code info: GTIN: 10809160370186 Lot Number: 1586050, 1586407, 1605747

UPC codes

10809160370186

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.