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
This recall has been terminated (originally issued June 11, 2008).
- Company
- Cardinal Health
- Recall Initiated
- February 12, 2008
- Posted
- June 11, 2008
- Terminated
- October 16, 2008
- Recall Number
- Z-1178-2008
- Quantity
- 16 cases
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The product has the potential of being non-sterile.
Distribution
USA Distribution: Kansas and Missouri
Lot / Code Info
Catalog SSI-0003, Mfg Date 10/15/07, Order no. 247610
Root Cause
Process control
Action Taken
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.