Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167, Teleflex Medical, Research Triangle Park, NC 27709
This recall has been terminated (originally issued April 9, 2009).
- Company
- Teleflex Medical
- Recall Initiated
- March 3, 2009
- Posted
- April 9, 2009
- Terminated
- March 31, 2011
- Recall Number
- Z-1178-2009
- Quantity
- 497 of all units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
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.
Lot / Code Info
Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9.
Root Cause
Process control
Action Taken
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.