Recall Z-1178-2008 ยท LRW Scissors, General, Surgical
Cardinal Health
Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalog #SSI-0003
| Date | Jun 11, 2008 (initiated Feb 12, 2008) |
| Status | Terminated |
| Reason | The product has the potential of being non-sterile. |
| Root cause | Process control |
| Action | Cardinal Health notified the accounts who ordered the affected scissors via letter dated 2/12/08, informing them that the scissors that were labeled sterile were subject to a sterility test failure. Upon review of the letter, the accounts were requested to inspect their inventory and immediately segregate any affected product and to telephone Cardinal Customer Sales Operations Group at 1-800-766-0706 for return instructions and to obtain credit/replacement. Any questions were directed to Cardinal's Quality Systems, Professional Services at 800-292-9332. |
| Quantity | 16 cases |
| Distribution | USA Distribution: Kansas and Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.