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 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 is classified as FDA Class II and involves a risk of additional surgical intervention, which aligns with the rubric criteria for Severe severity (Class II with significant injury/property-damage reports or structural defects).
Plain-English summary
Degania Silicone, Ltd. is recalling Cardinal Health Jackson-Pratt Channel Drains, 15FR, Full flutes (PN: JP-2188). The affected units are 15FR and 19FR round fluted drain channel drains. The recall covers 3,040 units distributed nationwide. The specific lot codes involved are P1849762, P1836201, and P1864643.
The recall is being issued 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, additional surgical intervention is required to remove the broken end from the patient's body.
Healthcare facilities and consumers should check their inventory for these specific lot codes and stop using the affected devices. If a patient has an affected drain in place, medical professionals should be aware of the potential for breakage during removal.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 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
- 3,040
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 Codes: P1849762
- P1836201
- P1864643
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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