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

FDA device recall Z-0113-2015 · posted 2014-10-22 · Terminated

Recall details

Recalling firm

Vygon Corporation

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

FOZ

Quantity affected

42250

Distribution

Worldwide Distribution - US including CA and Internationally to CA.

Date initiated

2014-08-28

Date posted

2014-10-22

Date terminated

2015-03-30

Location

Lansdale, PA

Related 510(k) clearances