Medline Silicone Drain Recalled for Risk of Breaking During Use
Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that requires additional surgical intervention to remove the broken device from the patient's body, meeting the criteria for significant injury reports.
Plain-English summary
Degania Silicone, Ltd. is recalling 200 units of Medline Silicone Drain 15Fr 3/16" Full Fluted (PN: DYNJWE2188HB, Lot Code: P1841839). The product is an introduction/drainage catheter intended to introduce nondrug fluids into body cavities or drain fluids from them.
The recall is due to a defect where the 15FR and 19FR round fluted drain channel drain may break during use, specifically at the connection point between the clear tube and the white profile part. This breakage typically occurs during removal of the device.
If the drain breaks, additional surgical intervention is required to remove the broken end from the patient's body. The affected units were distributed nationwide.
The recalled product
- Product
- Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body…
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 200
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 Code: P1841839
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Degania Silicone, Ltd. 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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