Device product
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Z-2054-2019
Product summary
- Event
- Event 82864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756/20-set cases
- Official record key
device-enforcement:Z-2054-2019
Official wording
Reason: Administration sets leaked at the filter.
Code information: Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.
Distribution pattern: Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
Administration sets leaked at the filter.