Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
What this means for you
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) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains, 10mm, 3/4 Ducts. These sterile, single-use medical devices are used to remove exudates from surgical wound sites. The recall is due to a potential compromise in the product's seal, which may affect the sterility of the package contents.
The use of the impacted products could result in an increased risk of infection. The recall covers specific catalog and lot numbers distributed nationwide. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for the affected catalog number (SU130-1309) and the listed lot numbers. If the product is found, it should be removed from use and returned to the supplier or the manufacturer.
The recalled product
- Product
- Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 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 radio-opaqu
- 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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