Devices

Device Recall ConvaTec

Model / Serial
Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
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.
Manufacturer
Convatec Inc.
1 Event
- Recall of Device Recall ConvaTec

Manufacturer

Convatec Inc.

Manufacturer Address
Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
Manufacturer Parent Company (2017)
Triona Holding Sa
Source
USFDA

One device with a similar name

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Device Recall ConvaTec

Model / Serial
Flexi-Seal Signal FMS Kit - ICC Code: 418000 SAP Code #1262167 Lot# 12-FM-01 and Lot# 12-FM-02.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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.
Manufacturer
Convatec Inc.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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