Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest comp
FDA device recall Z-2090-2014 · posted 2014-07-22 · Terminated
Recall details
- Recalling firm
- Zoll Circulation, Inc.
- Reason for recall
- Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
- Action taken
- Zoll Japan handled the recall.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DRM
- Quantity affected
- 161 Nickel Metal batteries, 40 LifeBand
- Distribution
- Distributed in Japan.
- Date initiated
- 2013-07-16
- Date posted
- 2014-07-22
- Date terminated
- 2014-07-22
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K040453) | Revivant Corp. | 2004-03-11 |
| MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (K032852) | Revivant Corp. | 2003-11-12 |
| AUTOPULSE RESUSCITATION SYSTEM (K022345) | Revivant Corp. | 2002-08-15 |
| AUTOPULSE, MODEL 100 (K011046) | Revivant Corp. | 2001-10-25 |