—#68284

Product

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 product code: LRW — Scissors, General, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog SSI-0003, Mfg Date 10/15/07, Order no. 247610

Why it was recalled

The product has the potential of being non-sterile.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: USA Distribution: Kansas and Missouri

Timeline

Recall initiated: 2008-02-12
Posted by FDA: 2008-06-11
Terminated: 2008-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68284. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.