Recall Z-0113-2015 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
| Date | Oct 22, 2014 (initiated Aug 28, 2014) |
| Status | Terminated |
| 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 an |
| Quantity | 42250 |
| Distribution | Worldwide Distribution - US including CA and Internationally to CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 Vygon Corp., Nov 30, 2007 |