Device product
Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
Z-2713-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1753 units
- Official record key
device-enforcement:Z-2713-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: a) REF CDS983998C, UDI/DI 40193489776714 (case), 10193489776713 (unit), Lot Numbers: 22HBC905, 22HBZ254, 23ABI006, 23CBJ920, 23EBN740, 23FBT058, 23GBR762, 23GBR790, 23JBN978, 23KBT038
Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Derived failure modes
-
Unknown
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.