| Class 2 Device Recall Pilling(R) Coronary Scissors | |
Date Initiated by Firm | March 03, 2009 |
Date Posted | April 09, 2009 |
Recall Status1 |
Terminated 3 on March 31, 2011 |
Recall Number | Z-1176-2009 |
Recall Event ID |
51300 |
Product Classification |
Surgical Scissors - Product Code LRW
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Product | Pilling(R) Coronary Scissors, 45Deg 7", Catalog numbers: 352165, 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
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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 |
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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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