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 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 (sterile medical device) where the hazard is an increased risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains, 15FR W/15FR Trocar. The affected products are sterile, single-use wound drainage systems intended for prescription use only. The recall covers specific catalog and lot numbers distributed nationwide.
The recall was initiated because the product's seal may be compromised, which could potentially compromise the sterility of the package contents. The use of these impacted products could result in an increased risk of infection for patients.
Healthcare providers and facilities should stop using the affected lots and contact Cardinal Health 200, LLC for further instructions on handling or returning the products.
The recalled product
- Product
- Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR 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…
- 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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