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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile OR Scissors

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  Class 2 Device Recall Sterile OR Scissors see related information
Date Initiated by Firm February 12, 2008
Date Posted June 11, 2008
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-1178-2008
Recall Event ID 46795
Product Classification surgical scissors - Product Code LRW
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
Code Information Catalog SSI-0003, Mfg Date 10/15/07, Order no. 247610
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer Reason
for Recall		 The product has the potential of being non-sterile.
FDA Determined
Cause 2		 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 in Commerce 16 cases
Distribution USA Distribution: Kansas and Missouri
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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