Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
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 medical device with unknown contamination (bioburden and particulates) where no specific illnesses or injuries have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health is recalling specific lots of GOWN SURG LG W/TOWEL ST BACK, Item Code 9515. The recall involves 7,659,634 total units that were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), the United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, the Dominican Republic, Israel, Mexico, Oman, Panama, the Philippines, and Saudi Arabia.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The source text does not specify the exact nature of the contaminants or report any specific illnesses or injuries associated with the product.
Affected lot numbers follow specific formats for single-sterile and bulk non-sterile products, generally involving items made in 2018 or 2019 with facility code 'J'. Consumers and healthcare facilities should stop using the affected gowns and contact Cardinal Health for instructions on return or disposal.
The recalled product
- Product
- GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Hazard
- Affected units
- 7,659,634
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 (2)
- 244 or greater is affected OR " " If made in 2019
- any value is affected
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cardinal Health 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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