Medical Device Recall: Silicone Fluted Round Drain and Connector
Degania Silicone, Ltd. is recalling Silicone Fluted Round Drain 24Fr and Connector units because sterile pouches are missing labels. The boxes are properly labeled, and only lot P1607442 is affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is an FDA Class III classification for a minor labeling error on the sterile pouches, which aligns with the Moderate criteria for minor labeling errors.
Plain-English summary
Degania Silicone, Ltd. has recalled the Silicone Fluted Round Drain 24Fr (hubless) and Connector, Sterile (Catalog Number JP-2234), which is used for the drainage of body fluids for surgical use.
The recall affects production lot P1607442 because the sterile pouches containing the device are missing labels. The outer boxes are properly labeled.
A total of 4,000 units were distributed in the United States and Puerto Rico. No injuries or health consequences have been reported.
Consumers or medical facilities should inspect their inventory for the affected lot and follow the recall instructions provided by the manufacturer.
The recalled product
- Product
- Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Surgical Drain
- Hazard
- Affected units
- 4,000
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 (1)
- Lot No P1607442.
Distribution
Distributed in 1 state:
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