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.
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 '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…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Wound Drainage
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 →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighDegania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise
FDA (Devices) · 2017-03-01
- HighCardinal Health Jackson-Pratt Channel Drain recalled for performance defects
FDA (Devices) · 2023-01-25
- HighCardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects
FDA (Devices) · 2023-01-25
- HighCardinal Health Jackson-Pratt Channel Drains recalled for performance defects
FDA (Devices) · 2023-01-25
- HighJackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments
FDA (Devices) · 2024-05-08
- HighCardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects
FDA (Devices) · 2023-01-25