Z-2762-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098
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
DYNJ908584 , Lot Numbers: 22DBL462; DYNJ908584 , Lot Numbers: 22JBS694; DYNJ908584 , Lot Numbers: 23CBQ227; DYNJ908584 , Lot Numbers: 23FBT227; DYNJ908584A, Lot Numbers: 23HBQ685; DYNJ908584A, Lot Numbers: 23JBT134; DYNJ908584A, Lot Numbers: 23LBE682; DYNJ908584A, Lot Numbers: 24CBH741; DYNJ909098 , Lot Numbers: 22LBS559; DYNJ909098 , Lot Numbers: 23EBQ496; DYNJ909098 , Lot Numbers: 23FBG194; DYNJ909098 , Lot Numbers: 23GBK039; DYNJ909098 , Lot Numbers: 23GBQ855; DYNJ909098 , Lot Numbers: 23IBK300; DYNJ909098 , Lot Numbers: 23IBQ772