ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error
Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.
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, which by definition is unlikely to cause adverse health consequences. The issue is limited to a packaging labeling error (duplicated lot numbers) with no reported injuries.
Plain-English summary
Convatec Inc. is recalling 22,896 units of ConvaTec Flexi-Seal Signal Plus, a prescription-only medical device used to manage fecal incontinence. The recall was initiated after the manufacturer identified a manufacturing irregularity related to the packaging of specific lots.
The issue involves the lot number convention being duplicated on the packaging for certain lots. The affected products are identified by ICC Code 418000, SAP Code 1705108, and Lots 12-FM-01 and 12-FM-02. These units were distributed nationwide in the United States.
Convatec notified customers on June 25, 2013, regarding this irregularity. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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.
- Manufacturer
- Convatec Inc.
- Hazard
- Affected units
- 22,896
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Flexi-Seal Signal + ICC Code 418000
- SAP Code# 1705108
- Lots 12-FM-01 and 12-FM-02.
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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