Recall Z-1179-2009 ยท LRW Scissors, General, Surgical
Teleflex Medical
Pilling(R) Coronary Scissors, 120Deg 7", Catalog numbers: 352168, Teleflex Medical, Research Triangle Park, NC 27709
| Date | Apr 9, 2009 (initiated Mar 3, 2009) |
| Status | Terminated |
| Reason | The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries. |
| Root cause | 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 fou |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.