Class III — Convatec Inc.
| Recalling firm | Convatec |
|---|---|
| Registered facility | CONVATEC TRIAD LIFE SCIENCES, LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| 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. |
| Product | ConvaTec Flexi-Seal SIGNAL Fecal Management System, 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. |
| Quantity | 22,896 units |
| Distribution | US Nationwide Distribution |
| Initiated | 2013-06-25 |
| Classified | 2013-08-20 |
| Terminated | 2014-01-08 |
| Recall number | Z-1990-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Convatec Inc. (Z-1990-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65879/
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