Z-2760-2024 Class II Ongoing
FDA device recall Z-2760-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 4, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
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 Pattern
Worldwide
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2760-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026