Recall Z-1407-04 ยท GBX Catheter, Irrigation
Cardinal Health
Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-1000; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
| Date | Aug 25, 2004 (initiated Jul 28, 2004) |
| Status | Terminated |
| Reason | The products labeled as sterile are not sterile. |
| Root cause | Other |
| Action | The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product. |
| Quantity | 60 cases |
| Distribution | Florida, Arizona, New Jersey and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.