Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, 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 consistent with the 'Severe' rubric criteria.
Plain-English summary
Degania Silicone, Ltd. is recalling Cardinal Health Jackson-Pratt Channel Drains (15FR and 19FR, full flutes) due to a risk of breakage during use. The device is a flexible tube intended to introduce nondrug fluids into body cavities or drain fluids from them.
The recall is issued because the drain may break at the connection point between the clear tube and the white profile part, mostly during removal. If the drain breaks, additional surgical intervention is required to remove the broken end from the patient's body.
The recall involves 4,080 units distributed nationwide. Affected lot codes are P1849695, P1858286, and P1867022. Healthcare providers should stop using these devices and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 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…
- Manufacturer
- Degania Silicone, Ltd.
- Affected units
- 4,080
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)
- Lot Code: P1849695
- P1858286
- P1867022
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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