Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat 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 (infection risk due to compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains, 7mm, Full Ducts. The recall is due to a potential compromise in the product's seal, which may affect the sterility of the package contents.
The affected products are sterile, single-use wound drainage systems intended for prescription use only. They consist of a wound drain and a fluid collection reservoir used to remove exudates from surgical wound sites. The recall covers specific catalog and lot numbers distributed nationwide.
Use of the 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 returns or replacement.
The recalled product
- Product
- Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. 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…
- 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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