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Terminated

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

FDA Recall Z-1178-2008 · Posted 2008-06-11

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeLRW
Date Initiated2008-02-12
Date Terminated2008-10-16
Product Quantity16 cases

Reason for Recall

The product has the potential of being non-sterile.

Firm 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.

Root Cause

Process control

Distribution Pattern

USA Distribution: Kansas and Missouri

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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