FDAFDA · Food and drugs·Recall number Z-1991-2013
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.
Published August 28, 2013 · Recall initiated: June 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Convatec Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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