Device recall event
Recall event 97615: Cook Medical Incorporated
FDA device recall · Class I · Open, Classified
Key facts
| Recall event number | 97615 |
|---|---|
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P140016 |
At a glance
- 1–9 Recalled products (Z-numbers)
- None Linked 510(k)s
- 1–9 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database