Recall Z-1406-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Cardinal Health
Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; 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 | 110 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.