Recall Z-1300-04 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
| Date | Jul 31, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated). |
| Root cause | Other |
| Action | The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization. |
| Quantity | 270 units |
| Distribution | The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.