FDA Medical Device Recalls (openFDA)
Perrigo Diabetes Care: Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
- Recall number
- Z-0990-2014
- Recalling firm
- Perrigo Diabetes Care
- Product
- Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
- Status
- Terminated
- Initiated
- 2013-12-20
- Posted
- 2014-02-19
- Terminated
- 2014-08-05
- Reason
- Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a
- Root cause
- Nonconforming Material/Component
- Action
- Perrigo Diabetes Care sent a recall notice dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate the affected productt and request return of all undistributed/unused sets from their customer warehouses to Omni Manufacturing Services S.A. de C.V., Parque Industrial Queretaro, La Noria Lt. 13. Mz 3 No. 125, Santo Rosa Jauregui, MX-76220 Santiago de Queretaro. Customers were instructed to distribute the attached "Urgent Field Safety Notice" to all users or patients who have been shipped any products from the affected lots. Customers with questions were instructed to call Perrigo Diabetes Care at 1-888-775-1997.
- Quantity
- 7924 units
- Distribution
- Nationwide Distribution including GA & TX
- Lot, serial or model codes
- 400064, 400069, 400070, & 400072 UPC: 7613117009502
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FKB
- Firm FEI
- 1811666
- Firm city
- Alpharetta
- Firm state
- GA
- 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