Device product
Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
Z-3032-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3032-2024
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: DYNJSYR12CP, Lot Number 19ABK425 ; DYNJSYR12CP, Lot Number 19ABK443 ; 148056, Lot Number 24DMC306; 148056, Lot Number 23LMI229; 148056, Lot Number 23JMH148; 148056, Lot Number 23JMA243; 148056, Lot Number 23IMB662; 148056, Lot Number 23HMG815; 150206, Lot Number 23LME712
Distribution pattern: Worldwide distribution.
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.