Device product
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Z-0356-2017
Product summary
- Firm
- Unomedical As
- Event
- Event 74242
- Status
- Terminated
- Classification
- Class II
- Quantity
- 664,000 units
- Official record key
device-enforcement:Z-0356-2017
Official wording
Reason: Tubing detachment
Code information: 5031810, 5034061, 5034232, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062780, 5062811, 5062812, 5062813, 5066512, 5066999, 5067219, 5067220, 5067221, 5067222, 5067223, 5067224, 5067225, 5067226, 5067574, 5068464, 5068465, 5071889, 5073670, 5073671, 5075505, 5075509, 5076078, 5054475, 5054476, 5054477, 5054478, 5063762, 5063763
Distribution pattern: Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Derived failure modes
-
Unknown
Tubing detachment