Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains
Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic 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 is classified as FDA Class II and involves a risk of infection from compromised sterility, but the source text explicitly states no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains, 19FR. These sterile, single-use medical devices are used to remove exudates from surgical wound sites by collecting blood and fluids into a reservoir. The recall is due to a potential compromise of the product's seal, which may affect the sterility of the package contents.
The affected products are identified by Catalog Number CT-HU1900 and Lot Numbers 1161200, 1161362, 1161455, and 1161599. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. The products were distributed nationwide.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices. Patients who have received these drains should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. 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 — Surgical Drains
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: CT-HU1900 Lot Numbers: 1161200 1161362 1161455 1161599
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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