Device recall
Z-0358-2017: Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5…
FDA device recall · Class II · Unomedical As
Key facts
| Recall number (Z-number) | Z-0358-2017 |
|---|---|
| Recall event | 74242 |
| 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… |
| Product code | FPA |
| Recalling firm | Unomedical As |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2016 |
| 510(k) numbers | K120872 |
| FEI number | 1000477110 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database