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U.S. Department of Health and Human Services

Class 2 Device Recall Orbit soft Infusion sets

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  Class 2 Device Recall Orbit soft Infusion sets see related information
Date Initiated by Firm December 20, 2013
Date Posted February 19, 2014
Recall Status1 Terminated 3 on August 05, 2014
Recall Number Z-0990-2014
Recall Event ID 67154
Product Classification Connector, blood tubing, infusion t - Product Code FKB
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.
Code Information 400064, 400069, 400070, & 400072 UPC: 7613117009502
Recalling Firm/
Manufacturer		 Perrigo Diabetes Care
3780 Mansell Rd Ste T50
Alpharetta GA 30022-1112
For Additional Information Contact Arthur Shannon
269-673-1709
Manufacturer 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
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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