Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling specific surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with unknown contamination levels, which poses a significant risk of infection or injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
Cardinal Health is recalling AAMI 3 Non-Radiopaque Surgical Gowns (Item Code 9575ELNA) due to the presence of an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall affects 7,659,634 total units.
The affected products 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. Specific lot numbers are identified by the facility code letter 'J' and production dates from 2018 or 2019.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions or a replacement.
The recalled product
- Product
- AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
- 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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