Z-0990-2014Class II

Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are...

Name: Z-0990-2014 Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are...
Creator: Perrigo Diabetes Care
Published: 2013-12-20
License: https://open.fda.gov/license/

L. Perrigo Company / initiated 2013-12-20 / Terminated / root cause: manufacturing process

FDA source

Perrigo Diabetes Care began a recall of 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... on 2013-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0990-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-20
Posted: 2014-02-19
Terminated: 2014-08-05
Recalling firm: L. Perrigo Company
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.
Product code: FKB Connector, Blood Tubing, Infusion T
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 7924 units
Distribution: Nationwide Distribution including GA & TX
Product codes and lots: 400064, 400069, 400070, & 400072 UPC: 7613117009502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0990-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0990-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19

Product code FKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)