Device product
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
Z-0358-2017
Product summary
- Firm
- Unomedical As
- Event
- Event 74242
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,114 units
- Official record key
device-enforcement:Z-0358-2017
Official wording
Reason: Tubing detachment
Code information: 5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964
Distribution pattern: Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Derived failure modes
-
Unknown
Tubing detachment