Device product
Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
Z-3053-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3053-2024
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: 613034700, Lot Number 20ADD340 ; 613034700, Lot Number 20BDC393 ; 613034700, Lot Number 20BDC472 ; 613034700, Lot Number 20BDC473 ; 613034700, Lot Number 20FDA390 ; 613034700, Lot Number 20FDA896 ; 613034700, Lot Number 20FDA897 ; 613034700, Lot Number 20FDA898 ; 613034700, Lot Number 20FDA896A; 613034700, Lot Number 20JDB120 ; 613034700, Lot Number 21CDA660 ; 613034700, Lot Number 21DDB193 ; 613034700, Lot Number 21IDA396 ; 613034700, Lot Number 21LDB900 ; 613034700, Lot Number 22ADB549 ; 613034701, Lot Number 21CDA617 ; 613034701, Lot Number 21DDB192 ; 613034701, Lot Number 21IDB791 ; 613034701, Lot Number 21JDB094 ; 613034701, Lot Number 22BDB700 ; 613034702, Lot Number 21CDA618 ; 613034702, Lot Number 21DDB222 ; 613034702, Lot Number 21IDB804 ; 613034702, Lot Number 21LDB713
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.