FDA Medical Device Recalls (openFDA)
Zevex Incorporated (dba Moog Medical Medical Devices Group): MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, 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-0701-2018
- Recalling firm
- Zevex Incorporated (dba Moog Medical Medical Devices Group)
- Product
- MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, 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
- 2017-11-10
- Posted
- not on file
- Terminated
- 2018-12-12
- Reason
- Particulate found on the Curlin spike.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers. The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.
- Quantity
- 2,417/20-administration set cases
- Distribution
- Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
- Lot, serial or model codes
- UDI 38148440000587, Lot/serial numbers: CF1517404, CF1519506, CF1521211, CF1519506, CF1522501, CF1526503, CF1530704, CF1530704, CF1530704, CF1611001, and CF1618152.
- 510(k) numbers
- ["K981816"]
- PMA numbers
- not on file
- Product code
- FPA
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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