Recall Z-2894-2011 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
| Date | Jul 29, 2011 (initiated Jun 17, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 95 kits |
| Distribution | Nationwide Distribution including the state of North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK Arrow International, Inc., Apr 23, 2003 |