3M Healthcare Business: 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

Hazard

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

Details from the source

Reason for recall: During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots. Distribution: Worldwide distribution. Quantity: 36,020 units Lot/code info: UDI/DI (01)30707387058204, Lot numbers: 33H9HW, 33HXMD, 33JKD4, 33JKLL, 33KPXJ

UPC codes

30707387058204

Source

Official record: FDA (Device enforcement) ↗

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