Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.
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 (medical device) where the defect compromises safety barriers, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29.8 million units of Cardinal Health Isolation Gowns, Lab Coats, and Kendall Gowns. The recall is due to a potential for manufacturing defects, including rips, holes, tears, incomplete or open seams, staining, and the presence of foreign material or debris on the products.
These gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids, and particulate material. The identified defects may compromise the integrity of the barrier, potentially exposing users to hazards the product is designed to prevent.
The affected products were distributed globally, including nationwide in the United States and in several international countries. All lot numbers from 18KXBXXXXX to 20KXBXXXXX are included in this recall. Health care facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions.
The recalled product
- Product
- Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Isolation Gowns
- Affected units
- 29,810,665
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)
- All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Distribution
Part of a larger recall action
This product is one of 13 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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