Device recall
Z-1994-2013: Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50…
FDA device recall · Class II · Getinge USA Inc
Key facts
| Recall number (Z-number) | Z-1994-2013 |
|---|---|
| Recall event | 65866 |
| Product | Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121C… |
| Product code | FRC |
| Recalling firm | Getinge USA Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2017 |
| 510(k) numbers | K093794 |
| FEI number | 3004147784 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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