Device product
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Z-2053-2019
Product summary
- Event
- Event 82864
- Status
- Terminated
- Classification
- Class II
- Quantity
- 569/20-set caess
- Official record key
device-enforcement:Z-2053-2019
Official wording
Reason: Administration sets leaked at the filter.
Code information: Lot numbers CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, UDI 38148440000464.
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.