Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactur
FDA device recall Z-2446-2010 · posted 2010-09-21 · Terminated
Recall details
- Recalling firm
- Chalgren Enterprises Inc
- Reason for recall
- Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
- Action taken
- Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- IKT
- Distribution
- Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.
- Date initiated
- 2007-04-12
- Date posted
- 2010-09-21
- Date terminated
- 2011-03-24
- Location
- Gilroy, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K912283) | Chalgren Enterprises, Inc. | 1992-03-16 |