Reported Aug 28, 2013 · Terminated
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of…
Convatec Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Convatec Inc. · 200 Headquarters Park Dr · Skillman, NJ · 08558-2600
Is this the product you have?
- ConvaTec Flexi-Seal SIGNAL +
- Rx Only Product UsageFor use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication
- Lot codes and dates
Flexi-Seal Signal + ICC Code 418000SAP Code# 1705108Lots 12-FM-01 and 12-FM-02
- Amount recalled
- 22,896 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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