The Recall Desk
HighFDA (Devices)·Z-2136-2017·Announced 2017-05-31

Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains

Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.

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 (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential infection risk without confirmed illness.

Plain-English summary

Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains, 19FR. These are sterile, single-use medical devices used to remove exudates from surgical wound sites. The recall involves specific catalog and lot numbers distributed nationwide.

The recall was initiated because the product's seal may be compromised, which could potentially compromise the sterility of the package contents. Use of the impacted products could result in an increased risk of infection.

Healthcare providers and facilities should check their inventory for the affected catalog and lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Jackson-Pratt Hemaduct 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 is a radio-opaque

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: JP-HUR190 Lot Numbers: 1161197 1161198 1161457 1161597

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 →