Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
Cardinal Health 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 is classified as FDA Class II. The hazard involves a risk of infection due to compromised sterility, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains. These are sterile, single-use wound drainage systems consisting of a wound drain and a fluid collection reservoir, intended for surgical use to remove exudates from wound sites.
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.
The affected products are identified by Catalog Number JP-HUF100 and Lot Numbers 1161357, 1161466, and 1170015. The products were distributed nationwide. Healthcare providers and facilities should stop using these specific lots and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Jackson-Pratt Hemaduct Silicone Flat Drain. 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…
- 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-HUF100 Lot Numbers: 1161357 1161466 1170015
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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