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FDA (Device enforcement)Recalled 2022-11-17class ii

MEDLINE INDUSTRIES, LP - Northfield: Non-sterile procedural trays labeled as LAPAROSCOPIC, 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: 260 cases (520 units) Lot/code info: Item Number: DYNJ900415L, UDI/GTIN Case: 40195327029426, UDI/GTIN Each: 10195327029425, Lot Numbers: 22HBO658, 22JBV699

UPC codes

40195327029426, 10195327029425

Source

Official record: FDA (Device enforcement)

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

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