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Recall Observatory FDA recall evidence

Device product

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 DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097

Z-2760-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94581
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2760-2024

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.