Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat 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 (infection risk due to compromised sterility) 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 Flat Drains, 10mm Full W/Trocar. The affected products are sterile, single-use medical devices used for wound drainage. The recall is limited to Catalog Number SU130-1411 and Lot Numbers 1161253, 1161516, and 1161692. The products were 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 identify and quarantine the affected lots. Patients who have received these specific devices should contact their healthcare provider for guidance.
The recalled product
- Product
- Jackson-Pratt Silicone Flat Drain, 10mm Full 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…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Wound Drainage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: SU130-1411 Lot Numbers: 1161253 1161516 1161692
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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