Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 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 medical device where the sterility may be compromised, leading to 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 specific lots of Jackson-Pratt Silicone Flat Drains, 10mm, Full Ducts. 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 in the product's seal, which may affect the sterility of the package contents.
The affected products are distributed nationwide. The recall covers specific catalog number SU130-1311 and a list of 34 specific lot numbers, including 1161247 through 1161252, 1161414 through 1161421, 1161509 through 1161515, 1161622 through 1161628, and 1170089 through 1170356. The source text does not specify the number of units recalled or the exact dates of distribution.
Use of the impacted products could result in an increased risk of infection. Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these devices. Consumers should not use these products and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Jackson-Pratt Silicone Flat Drain, 10mm, 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 — 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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