Device product
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
Z-2709-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1700 units
- Official record key
device-enforcement:Z-2709-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: a) REF DYKM2169, UDI/DI 40195327199969 (case), 10195327199968 (unit), Lot Numbers: 22IBJ207, 22LBP008, 23ABT182, 23BBK494, 23EBN628, 23GBF762, 23IBF429, 23JBH402, 23LBB872
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.