Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling AAMI 3 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 aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Cardinal Health is recalling AAMI 3 FABREINF SURG GOWN LARGE (Item Code 9511) due to the presence of an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall involves 7,659,634 total units.
The affected gowns were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. Specific lot numbers are identified by the facility code letter 'J' and specific year/month formats for 2018 and 2019 as detailed in the agency's recall notice.
The recalled product
- Product
- AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
- 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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