Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise leading to infection risk) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains, 19FR. These sterile, single-use medical devices are used to remove exudates from surgical wound sites. The recall is due to a potential compromise in the product's seal, which could affect the sterility of the package contents.
The affected products are identified by Catalog Number SU130-1325 and specific lot numbers: 1161208, 1161209, 1161376, 1161479, 1161480, 1161612, 1161613, and 1170040. The products were distributed nationwide.
Use of the impacted products could result in an increased risk of infection. Healthcare providers and patients should check their inventory for the affected lot numbers and discontinue use of these specific units.
The recalled product
- Product
- Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drains
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Cardinal Health 200, LLC 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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