Recall Z-2584-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Telefelx Medical
WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time a
| Date | Sep 27, 2010 (initiated Jul 30, 2010) |
| Status | Terminated |
| Reason | Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes. |
| Root cause | Other |
| Action | Teleflex Medical sent an "Urgent Medical Device Recall" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately f |
| Quantity | 190,344 eaches |
| Distribution | Worldwide distribution: USA and countries of Canada, Australia and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.