Cook Incorporated: COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.

Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Details from the source

Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Distribution: Worldwide distribution. Quantity: 104 units Lot/code info: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.

UPC codes

00827002565371

Source

Official record: FDA (Device enforcement) ↗

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