Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
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 (medical barrier protection) where the defect could compromise safety, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling approximately 29,810,665 units of Lab Coats SMS Large White (SKU 2302LC), Cardinal Health Isolation Gowns, and Kendall Gowns. These products 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 where minimal fluid settings are expected.
The recall is being conducted because there is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris on the gowns and lab coats. These defects may compromise the intended barrier protection of the products.
The affected products were distributed globally, including nationwide in the United States and in Australia, Canada, Chile, Israel, Japan, the Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland, and the United Arab Emirates. The recall includes all lot numbers from 18KXBXXXXX to 20KXBXXXXX. Health care facilities and consumers should stop using these products and contact Cardinal Health for further instructions.
The recalled product
- Product
- Lab Coats SMS Large White, SKU 2302LC 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 mate
- Manufacturer
- Cardinal Health 200, LLC
- 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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