MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68

Hazard

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Details from the source

Reason for recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 808 units Lot/code info: 1) Pack Number DYNJ62734A: UDI/DI 10193489242225 (each) 40193489242226 (case), Lot Number 21IME904A; 2) Pack Number DYNJ44115A: UDI/DI 10889942308187 (each) 40889942308188 (case), Lot Number 21EMF484A; 3) Pack Number DYNJ68393A: UDI/DI 10193489939996 (each) 40193489939997 (case), Lot Number 22KBW583A

UPC codes

10193489242225, 40193489242226, 10889942308187, 40889942308188, 10193489939996, 40193489939997

Source

Official record: FDA (Device enforcement) ↗

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