Device product
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. 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-1342-2018
Product summary
- Event
- Event 79077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,500 pouches
- Official record key
device-enforcement:Z-1342-2018
Official wording
Reason: The infusion sets were manufactured with an incorrect spin collar.
Code information: Lot numbers 3474877, UDI (01) 0 0887709 074578 (30) 500 (10)3474877; and Lot number 3481246, UDI (01) 0 0887709 074578 (30) 500 (10) 3481246.
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.