Z-2584-2010

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

Name: Z-2584-2010 WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade...
Creator: Telefelx Medical
Published: 2010-07-30
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2010-07-30 / Terminated

FDA source

Telefelx Medical began a recall of 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... on 2010-07-30. The reason FDA records is "Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2584-2010
Status: Terminated
Initiated: 2010-07-30
Posted: 2010-09-27
Terminated: 2011-04-21
Recalling firm: Teleflex Medical
Product: 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 and then disposed.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.
FDA 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 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.
Quantity in commerce: 190,344 eaches
Distribution: Worldwide distribution: USA and countries of Canada, Australia and Singapore.
Product codes and lots: Catalog number: 809335, Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449.

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)