MEDLINE INDUSTRIES, LP - Northfield: Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK

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: 398 Lot/code info: 1) Pack Number DYNJ0826753O : UDI/DI 10193489384291 (each) 40193489384292 (case), Lot Number 23GMB253A; 2) Pack Number DYNJ56717A : UDI/DI 10889942897940 (each) 40889942897941 (case), Lot Number 21EBM603A; 3) Pack Number CVI5065 : UDI/DI 10195327504366 (each) 40195327504367 (case), Lot Number 23LMH242A; 4) Pack Number DYNJ46648D : UDI/DI 10193489755244 (each) 40193489755245 (case), Lot Number 20HMC528A; 5) Pack Number DYNJ0774005G : UDI/DI 10193489271485 (each) 40193489271486 (case), Lot Number 21EMA842Z; 6) Pack Number DYNJ32773G : UDI/DI 10193489766134 (each) 40193489766135 (case), Lot Number 21IMG907A; 7) Pack Number PHS656578F : UDI/DI 10889942804535 (each) 40889942804536 (case), Lot Number 20LKB006A

UPC codes

10193489384291, 40193489384292, 10889942897940, 40889942897941, 10195327504366, 40195327504367, 10193489755244, 40193489755245, 10193489271485, 40193489271486, 10193489766134, 40193489766135, 10889942804535, 40889942804536

Source

Official record: FDA (Device enforcement) ↗

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