Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
What this means for you
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 voluntarily recalling the Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. The recall involves sterile, single-use wound drainage systems consisting of a wound drain and a fluid collection reservoir. These devices are used to remove exudates from surgical wound sites.
The recall was initiated because the product's seal may be compromised, which could potentially compromise the sterility of the package contents. Use of the impacted products could result in an increased risk of infection. The affected products are identified by Catalog Number SU130-0321 and specific lot numbers including 1161202, 1161203, 1161364, 1161365, 1161471, 1161472, 1161601, 1161602, 1170030, and 1170031.
The products were distributed nationwide. Healthcare providers and facilities should stop using the affected lots and follow the recall instructions provided by the manufacturer.
The recalled product
- Product
- Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. 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 radi
- 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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