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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ

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 Lot/code info: DYKM1426 , Lot Numbers: 21HME852; DYKM1426 , Lot Numbers: 21JMB937; DYKM1426 , Lot Numbers: 22AMC931; DYKM1426 , Lot Numbers: 22BMH636; DYKM1426 , Lot Numbers: 22GMC855; DYKM1426 , Lot Numbers: 22HMD453; DYKM1426 , Lot Numbers: 22JMA597; DYKM1426 , Lot Numbers: 22LMF030; DYKM1426 , Lot Numbers: 23JMB439; DYKM1426 , Lot Numbers: 24AMF833; DYNJ908583, Lot Numbers: 23BBI474; DYNJ908583, Lot Numbers: 23GBU194; DYNJ908583, Lot Numbers: 23HBI662; DYNJ908583A , Lot Numbers: 23HBU557; DYNJ908583A , Lot Numbers: 23JBD374; DYNJ908583A , Lot Numbers: 23KBO704; DYNJ908583A , Lot Numbers: 23KBW138; DYNJ908583A , Lot Numbers: 24ABB089; DYNJ908583A , Lot Numbers: 24BBD662; DYNJ908583A , Lot Numbers: 24BBS919; DYNJ908583A , Lot Numbers: 24CBB994; DYNJ909097, Lot Numbers: 23EBQ501; DYNJ909097, Lot Numbers: 23FBH520; DYNJ909097, Lot Numbers: 23GBD905; DYNJ909097, Lot Numbers: 23HBP109; DYNJ909097, Lot Numbers: 23HBY982; DYNJ909097, Lot Numbers: 23IBM281

Source

Official record: FDA (Device enforcement)

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

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