WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is use

FDA device recall Z-2584-2010 · posted 2010-09-27 · Terminated

Recall details

Recalling firm

Telefelx Medical

Reason for recall

Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.

Action taken

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 four to six seeks 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 as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Other

Status

Terminated

Product code

GEI

Quantity affected

190,344 eaches

Distribution

Worldwide distribution: USA and countries of Canada, Australia and Singapore.

Date initiated

2010-07-30

Date posted

2010-09-27

Date terminated

2011-04-21

Location

Durham, NC