Z-0771-2014Class II

Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research...

Name: Z-0771-2014 Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research...
Creator: Teleflex Medical
Published: 2013-12-19
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2013-12-19 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and... on 2013-12-19. FDA classified it as Class II and gives the reason as "Sterility cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0771-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-01-15
Terminated: 2016-05-20
Recalling firm: Teleflex Medical
Product: Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Sterility cannot be guaranteed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received product.
Quantity in commerce: 17,450 ea
Distribution: Nationwide Distribution.
Product codes and lots: Catalog Number: 809610, Lot Number: 01A1100610.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0770-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14
Z-0771-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-14

Product code GEI

K881413Class IIElectro-Cautery Suction TubeAlto Development Corp. / cleared 1988-04-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)