Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next
FDA device recall Z-2894-2011 · posted 2011-07-29 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed.
- Action taken
- Arrow International, Inc. sent an "Urgent Medical Device Recall" letter dated June 17, 2011 to all affected customers. The letter describes the problem and provides recommendations including; quarantine affected product, return of product, and send an acknowledgement form back to manufacturer. For additional information call 800 233-3187.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 95 kits
- Distribution
- Nationwide Distribution including the state of North Carolina.
- Date initiated
- 2011-06-17
- Date posted
- 2011-07-29
- Date terminated
- 2012-10-01
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (K030937) | Arrow International, Inc. | 2003-04-23 |