Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
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 High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains, 10FR. Sterile, Rx Only. The recall involves specific catalog and lot numbers distributed nationwide. These sterile, single-use wound drainage systems consist of a wound drain and a fluid collection reservoir used to remove exudates from surgical wound sites.
The recall was initiated because the product's seal may be compromised, which potentially compromises the sterility of the package contents. The use of impacted products could result in an increased risk of infection.
Healthcare providers and facilities should stop using the affected lots and contact Cardinal Health 200, LLC for further instructions on return or replacement.
The recalled product
- Product
- Jackson-Pratt Silicone Round Drain, 10FR. 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 — Wound Drainage
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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