Device recall
Z-1948-2014: Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000…
FDA device recall · Class I · Ventlab LLC
Key facts
| Recall number (Z-number) | Z-1948-2014 |
|---|---|
| Recall event | 68242 |
| Product | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual… |
| Product code | BTM |
| Recalling firm | Ventlab LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 17, 2015 |
| 510(k) numbers | K012842, K953546, K982215 |
| FEI number | 1314417 |
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