FDA Medical Device Recalls (openFDA)
Zevex Incorporated (dba MOOG Medical Devices Group): 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.
- Recall number
- Z-2053-2019
- Recalling firm
- Zevex Incorporated (dba MOOG Medical Devices Group)
- 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.
- Status
- Terminated
- Initiated
- 2019-02-27
- Posted
- 2019-07-23
- Terminated
- 2021-04-28
- Reason
- Administration sets leaked at the filter.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued a letter dated 2/27/2019 via regular mail on 2/272019 to their direct accounts describing the issue, risk to health, and the necessary actions to be taken.
- Quantity
- 569/20-set caess
- Distribution
- Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot numbers CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, UDI 38148440000464.
- 510(k) numbers
- ["K981816"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1000117172
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28