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FDA (Device enforcement)Recalled 2024-11-21class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120

Hazard

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Details from the source

Reason for recall: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. Distribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada. Quantity: 74 units Lot/code info: 1) REF DYNJ69476, UDI/DI 10193489947786 (EA) 40193489947787 (CS), Lot Numbers: 21HDB296; 2) REF DYNJ910120, UDI/DI 10195327589202 (EA) 40195327589203 (CS), Lot Numbers: 24CMH776.

UPC codes

10193489947786, 40193489947787, 10195327589202, 40195327589203

Source

Official record: FDA (Device enforcement)

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

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