Sklar Instruments: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number

Hazard

Reports of various packaging issues that may result in a breach of the sterile barrier.

Details from the source

Reason for recall: Reports of various packaging issues that may result in a breach of the sterile barrier. Distribution: Domestic: Nationwide Distribution Quantity: 1050 units Lot/code info: 1) 96-2243, UDI/DI 50649111493087Lot codes: SK-115, SK-116, SK-129; 2) 96-2243M, UDI/DI 50649111448605Lot codes: SK-129; 3) 96-2267, UDI/DI 50649111448698Lot codes: SK-117; 4) 96-2267A, UDI/DI 50649111487604Lot codes: SK-112; 5) 96-2269A, UDI/DI 50649111487611Lot codes: SK-112; 6) 96-2959, UDI/DI 50649111493070Lot codes: SK-118.

Source

Official record: FDA (Device enforcement) ↗

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