Device product
7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Z-1344-2018
Product summary
- Event
- Event 79077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 pouches
- Official record key
device-enforcement:Z-1344-2018
Official wording
Reason: The infusion sets were manufactured with an incorrect spin collar.
Code information: Lot number 3483247, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3483247; lot number 3484722, UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3484722; and lot number 3489328, UDI (01) 0 0887709 08949 5 (17) 220701 (30) 01 (10) 3489328.
Distribution pattern: Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
Derived failure modes
-
Unknown
The infusion sets were manufactured with an incorrect spin collar.