Recall Z-1991-2013— Convatec Inc.

Name: FDA recall Z-1991-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-25

Class III · Terminated

Class III FDA medical device recall by Convatec Inc., initiated 2013-06-25, terminated 2014-01-08. It names one FDA 510(k) clearance: K032734. Product: ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.. Reason: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging..

Recalling firm: Convatec Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-06-25
Terminated: 2014-01-08
Firm location: Skillman, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K032734 — CONVATEC FECAL MANAGEMENT SYSTEMConvatec, A Bristol-Myers Squibb Co.·cleared 2004-04-08

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

ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.

Reason for recall

ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.

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