Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel 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 involves a medical device defect that requires additional surgical intervention to remove broken parts from a patient's body, which constitutes a significant injury risk and fits the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Degania Silicone, Ltd. is recalling Cardinal Health Jackson-Pratt Channel Drains (15FR and 19FR, full flutes, with trocar). The specific product identified is PN: JP-2191. The recall involves 6,960 units that were distributed nationwide.
The recall is being issued because the drain channel may break during use, most commonly during removal. The breakage occurs at the connection point between the clear tube and the white profile part. If the device breaks, additional surgical intervention is required to remove the broken end from the patient's body.
The affected lot codes are P1861538, P1865416, and P1903570. Healthcare providers and consumers should stop using these devices and contact Degania Silicone, Ltd. for instructions on how to return the product.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 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…
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Surgical Drains
- Affected units
- 6,960
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 Codes: P1861538 P1865416 P1903570
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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