Agency classClass IIOur severity:High FDA (Devices)·Z-2147-2017·Announced 2017-05-31

Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns

Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round 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 (sterility compromise leading to infection risk) 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 voluntarily recalling specific lots of Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. The affected products are sterile, single-use wound drainage systems consisting of a wound drain and a fluid collection reservoir. These devices are surgically placed in wound sites to remove exudates and collect blood and fluids.

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 impacted products could result in an increased risk of infection. The recall covers specific catalog number SU130-1323 and lot numbers 1161373, 1161374, 1161375, 1161610, 1161611, 1170038, and 1170039. The products were distributed nationwide.

Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the affected products are found, they should be removed from use and returned to the supplier or the recalling firm. Because these are prescription-only, single-use medical devices, patients should consult their healthcare provider if they have questions regarding the use of these specific devices.

The recalled product

Product: Jackson-Pratt Silicone Round Drain, 15FR. 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-opaque section…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drainage
Hazard: infection
sterility-compromise

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.

See all 20 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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