FDA Enforcement
Class II
Terminated
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Recall: Z-0358-2017
·
Reported November 9, 2016
Enforcement
- Recall Number
- Z-0358-2017
- Event ID
- 74242
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Unomedical As
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 9, 2016
- Initiation Date
- November 7, 2014
- Classification Date
- November 3, 2016
- Termination Date
- November 16, 2016
- Address
- Aholmvej 1 3 Osted, Roskilde, N/A, Denmark
Description
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Reason
Tubing detachment
Code Info
5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964
Distribution
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Quantity
22,114 units