FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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.
- Recall number
- Z-0771-2014
- 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.
- Status
- Terminated
- Initiated
- 2013-12-19
- Posted
- 2014-01-15
- Terminated
- 2016-05-20
- Reason
- Sterility cannot be guaranteed.
- 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
- 17,450 ea
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Catalog Number: 809610, Lot Number: 01A1100610.
- 510(k) numbers
- ["K881413"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28