The Recall Desk
HighFDA (Devices)·Z-2133-2017·Announced 2017-05-31

Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains

Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat 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 (sterility compromise leading to infection risk) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.

Plain-English summary

Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains, 10mm, Full Ducts W/15FR Trocar. The affected products are sterile, single-use wound drainage systems consisting of a wound drain and a fluid collection reservoir. The recall is limited to Catalog Number JP-HUF101, Lot Number 1161358, which were distributed nationwide.

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 these impacted products could result in an increased risk of infection.

These devices are prescription-only and intended for single patient use. Healthcare facilities and providers should stop using the affected lots and contact Cardinal Health 200, LLC for further instructions on how to return or dispose of the products.

The recalled product

Product
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. 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 w

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-HUF101 Lot Numbers: 1161358

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 →