Device product
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.
Z-1991-2013
Product summary
- Firm
- Convatec Inc.
- Event
- Event 65879
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,896 units
- Official record key
device-enforcement:Z-1991-2013
Official wording
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.
Code information: Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.