MEDLINE INDUSTRIES, LP - Northfield: Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case

Hazard

Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

Details from the source

Reason for recall: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. Distribution: US Nationwide distribution in the states of AR, MD, WA, WI. Quantity: 57 cases (114 units) Lot/code info: Item Number: CDS980894A, UDI/GTIN Case: 40889942401292, UDI/GTIN Each: 10889942401291, Lot Numbers: 22HMD613, 22JMB665

UPC codes

40889942401292, 10889942401291

Source

Official record: FDA (Device enforcement) ↗

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