Device recall
Z-0965-2023: CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c)…
FDA device recall · Class I · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0965-2023 |
|---|---|
| Recall event | 91392 |
| Product | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device |
| Product code | FPA |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K162219 |
| FEI number | 3012307300 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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