Z-0113-2015Class II

Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system...

Name: Z-0113-2015 Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system...
Creator: Vygon Corporation
Published: 2014-08-28
License: https://open.fda.gov/license/

Vygon U.S.A. / initiated 2014-08-28 / Terminated / root cause: design

FDA source

Vygon Corporation began a recall of Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection... on 2014-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0113-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-28
Posted: 2014-10-22
Terminated: 2015-03-30
Recalling firm: Vygon U.S.A.
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 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 tag: design
FDA 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 in commerce: 42250
Distribution: Worldwide Distribution - US including CA and Internationally to CA.
Product codes and lots: Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-22

Product code FOZ

K070705Class IIModification to: Latex-Free Bionector, Model# 896.019, 896.039Vygon Corp. / cleared 2007-11-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)