Z-2053-2019 Class II Terminated
FDA device recall Z-2053-2019 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: 569/20-set caess.
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
- 569/20-set caess
Product Description
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.
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 CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, UDI 38148440000464.