Z-0355-2017 Class II Terminated
FDA device recall Z-0355-2017 was initiated by Unomedical As on November 7, 2014 and is designated Class II. Reason for recall: Tubing detachment The recall status is terminated (terminated November 16, 2016). Affected quantity: 1,295,515 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2016
- Initiation Date
- November 7, 2014
- Termination Date
- November 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,295,515 units
Product Description
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Reason for Recall
Tubing detachment
Distribution Pattern
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Code Information
5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5066981, 5066984, 5066992, 5067121, 5067122, 5067123, 5067124, 5067126, 5067127, 5067128, 5067129, 5067130, 5067131, 5067132, 5067133, 5067134, 5067137, 5070832, 5071891, 5071892, 5075507, 5075508, 5075510, 5075533, 5076039, 5077501, 5035530, 5035531, 5035532, 5054472, 5054473, 5054474, 5054479, 5054480, 5063759, 5063760, 5063761