Device recall
Z-2331-2014: PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15"…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2331-2014 |
|---|---|
| Recall event | 68536 |
| Product | PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE SHEET 41 " X 58" SMS (2) LEGGINS… |
| Product code | OKV |
| Recalling firm | Customed, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| FEI number | 2648727 |
At a glance
- None Linked 510(k)s
- 100–999 Products in the same recall event
- 10–99 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