Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
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 involves a medical device defect that requires additional surgical intervention to remove broken parts from the patient's body, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Degania Silicone, Ltd. is recalling 640 units of Cardinal Health Jackson-Pratt Channel Drains (15FR and 19FR). The affected products are identified by lot codes 1900956 and P1900955 and were distributed nationwide.
The recall was initiated because the drain channel may break during use, specifically at the connection point between the clear tube and the white profile part. This breakage is most likely to occur during removal of the device.
If the drain breaks, the broken end may remain in the patient's body, requiring additional surgical intervention to remove it. Healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 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…
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 640
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 (2)
- Lot Codes: 1900956
- P1900955
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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