Device product
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Z-1995-2021
Product summary
- Firm
- CAREFUSION
- Event
- Event 88104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-1995-2021
Official wording
Reason: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Code information: Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Distribution pattern: U.S.: TN O.U.S.: None
Derived failure modes
-
Unknown
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.