Cardinal Health Recalls AAMI 3 Fabric Reinforced Gowns Due to Contamination
Cardinal Health is recalling AAMI 3 Fabric Reinforced Gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by unknown bioburden/microbiological flora in medical devices) fall under the 'Severe' category (Score 4), as they are not Class I but involve significant health risks.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 Fabric Reinforced Gowns, Item Code 9571NA. The recall is being conducted because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The affected products were distributed worldwide, including in 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 covers specific lot numbers manufactured in 2018 and 2019, identified by specific alphanumeric codes provided in the official notice.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on how to return or dispose of the product. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
- 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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