Recall Z-0113-2015— Vygon Corporation

Name: FDA recall Z-0113-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-28

Class II · Terminated

Class II FDA medical device recall by Vygon Corporation, initiated 2014-08-28, terminated 2015-03-30. It names one FDA 510(k) clearance: K070705. 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.. 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..

Recalling firm: Vygon Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-08-28
Terminated: 2015-03-30
Firm location: Lansdale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039Vygon Corp.·cleared 2007-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.