Z-2054-2019 Class II Terminated
FDA device recall Z-2054-2019 was initiated by Zevex Incorporated (dba MOOG Medical Devices Group) on February 27, 2019 and is designated Class II. Reason for recall: Administration sets leaked at the filter. The recall status is terminated (terminated April 28, 2021). Affected quantity: 756/20-set cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- February 27, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 756/20-set cases
Product Description
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.
Reason for Recall
Administration sets leaked at the filter.
Distribution Pattern
Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
Code Information
Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.