ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through
FDA device recall Z-1990-2013 · posted 2013-08-20 · Terminated
Recall details
- Recalling firm
- Convatec Inc.
- 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.
- Action taken
- ConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 22,896 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-06-25
- Date posted
- 2013-08-20
- Date terminated
- 2014-01-08
- Location
- Skillman, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONVATEC FECAL MANAGEMENT SYSTEM (K032734) | Convatec, A Bristol-Myers Squibb Co. | 2004-04-08 |