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U.S. Department of Health and Human Services

Class 2 Device Recall Pilling(R) Coronary Scissors

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  Class 2 Device Recall Pilling(R) Coronary Scissors see related information
Date Initiated by Firm March 03, 2009
Date Posted April 09, 2009
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-1178-2009
Recall Event ID 51300
Product Classification Surgical Scissors - Product Code LRW
Product Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167, Teleflex Medical, Research Triangle Park, NC 27709
Code Information Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael Taggart
919-433-4816
Manufacturer Reason
for Recall		 The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent Medical Device Recall letter, dated 03/03/2009, via UPS Next Day. Hospitals were instructed to immediately discontinue use of the products, inspect the scissors for the date codes and to return the product to Teleflex Medical for replacement. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be completed and faxed back to Teleflex Medical. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected product retrieved by Teleflex Medical will be destroyed and replacement product provided to the consignee. Records of destruction will be maintained.
Quantity in Commerce 497 of all units
Distribution Worldwide Distribution -- USA including states of AL, AZ, CA, CO, DC, DE, FL, IA, IN, KS, MA, MD, MI, MO, MS, NH, NJ, NY, NV, OH, OK, OR, PA, RI, TN, TX, UT, and WA, and countries of Australia, Canada, France, Germany, India, Japan, and Singapore.
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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