ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error
Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source text identifies the issue as a packaging irregularity (duplicated lot number convention) without reporting any injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Convatec Inc. is recalling 22,896 units of the ConvaTec Flexi-Seal SIGNAL Fecal Management System. This prescription-only medical device is used to manage fecal incontinence by collecting liquid to semi-liquid stool and providing access to administer medication. The recall covers specific lots (Lot# 12-FM-01 and Lot# 12-FM-02) distributed nationwide in the United States.
The recall was initiated due to a manufacturing irregularity related to the packaging of these specific lots. In the affected units, the lot number convention was duplicated on the packaging. Convatec notified its customers regarding this issue on June 25, 2013.
Consumers and healthcare providers should stop using the affected Flexi-Seal Signal Fecal Management System kits and contact Convatec Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Convatec Inc.
- Hazard
- Affected units
- 22,896
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Convatec Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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