FDA Medical Device Recalls (openFDA)
Vygon Corporation: Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
- Recall number
- Z-0113-2015
- Recalling firm
- Vygon Corporation
- Product
- Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
- Status
- Terminated
- Initiated
- 2014-08-28
- Posted
- 2014-10-22
- Terminated
- 2015-03-30
- Reason
- Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
- Root cause
- Component design/selection
- Action
- Vygon sent an Urgent Medical Device Recall letter dated August 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for the affected product and immediately cease distribution, and quarantine all affected product immediately. Count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form. Customers were asked to fax or email the form to Vygon including customer contact information. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. Customers were instructed to return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. All inventory will be credited at no cost to the customer. For questions regarding this recall call 800-473-5414.
- Quantity
- 42250
- Distribution
- Worldwide Distribution - US including CA and Internationally to CA.
- Lot, serial or model codes
- Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.
- 510(k) numbers
- ["K070705"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2245270
- Firm city
- Lansdale
- Firm state
- PA
- 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