Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially 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 the broken part from the patient's body, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk device failures.
Plain-English summary
Degania Silicone, Ltd. is voluntarily recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains (15FR and 19FR round fluted) with lot codes P1851056 and P1867059. The devices were distributed nationwide. The recall is due to a defect where the drain may break at the connection point between the clear tube and the white profile part, typically during removal.
The breakage can leave a portion of the device inside the patient, which may require additional surgical intervention to remove the broken end. The recalled product is an introduction/drainage catheter intended to drain fluids from body cavities.
Healthcare providers and facilities should stop using these specific lots and contact the recalling firm for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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.
- Affected units
- 2,160
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: P1851056 P1867059
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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