Device product
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
Z-2762-2024
Product summary
- Event
- Event 94581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2762-2024
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: 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
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
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.