Recall Z-1080-2015 ยท CAZ Anesthesia Conduction Kit
Arrow International Inc
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
| Date | Feb 10, 2015 (initiated Jan 5, 2015) |
| Status | Terminated |
| Reason | The product labeling does not specify the 5 year shelf life of the product. |
| Root cause | Labeling design |
| Action | Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product. |
| Quantity | 63022 |
| Distribution | Distribution US Nationwide, Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884552 | CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER Arrow Intl., Inc., Mar 14, 1989 |