FDA Device recall Z-0358-2017
Comfort 5+5 Pack w/110cm Tube & 17mm Cann
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Comfort 5+5 Pack w/110cm Tube & 17mm Cann by Unomedical As, citing tubing detachment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0358-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-07 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Unomedical As |
| Distribution | CA, IN, PA |
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
Reason
Tubing detachment
Identifiers
| upc | 389110141477 |
|---|---|
| upc | 389110141279 |
| upc | 389110141439 |
| upc | 389110141231 |
| code_info | 5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0358-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.