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

MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

Hazard

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Details from the source

Reason for recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. Quantity: 100 cases (156 units) Lot/code info: a. MAJOR CDS-LF, Item Number: CDS983861D, Case UDI/GTIN: 40193489524353, Unit UDI/GTIN: 10193489524352, Lot Number: 22JDB004; b. BURN PACK-LF, Item Number: DYNJ0781678S, Case UDI/GTIN: 40193489226349, Unit UDI/GTIN: 10193489226348, Lot Number: 22IMC056; c. BURN PACK, Item Number: DYNJ82534, Case UDI/GTIN: 40195327198504, Unit UDI/GTIN: 10195327198503, Lot Number: 22HBI219; d. SMALL BURN, Item Number: DYNJ901793L, Case UDI/GTIN: 40193489955065, Unit UDI/GTIN: 10193489955064, Lot Number: 22KBB743,22IBH124

UPC codes

40193489524353, 10193489524352, 40193489226349, 10193489226348, 40195327198504, 10195327198503, 40193489955065, 10193489955064

Source

Official record: FDA (Device enforcement)

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

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