Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling AAMI 3 non-reinforced 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 levels (bioburden and particulates), representing a risk of harm where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 non-reinforced surgical gowns (Item Code 9585, Size 3XL). The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The affected products were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), Canada, Australia, and various countries in the Middle East, South America, and Asia. The recall covers specific lot numbers manufactured in 2018 and 2019, identified by specific alphanumeric codes indicating the facility and production date.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- 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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