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.
Reported: August 28, 2013 Initiated: June 25, 2013 #Z-1991-2013
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.
Details
- Recalling Firm
- Convatec Inc.
- Units Affected
- 22,896 units
- Distribution
- US Nationwide Distribution
- Location
- Skillman, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Convatec Inc.. Units affected: 22,896 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Low. Recall number: Z-1991-2013.
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