Device product
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, 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-1343-2018
Product summary
- Event
- Event 79077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 pouches
- Official record key
device-enforcement:Z-1343-2018
Official wording
Reason: The infusion sets were manufactured with an incorrect spin collar.
Code information: Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590.
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.