Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 fabric-reinforced 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 meets the rubric criteria for a Severe rating (Score 4) due to the potential for significant injury or adverse health consequences.
Plain-English summary
Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns (Item Code 9541) in size XL. 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 agency has classified this recall as Class II.
Healthcare facilities and consumers should stop using the affected gowns immediately. Affected lots are identified by specific lot number formats for single-sterile and bulk non-sterile products manufactured in 2018 or 2019 at facility code J. Users should check their inventory against the lot number specifications provided in the official recall notice to determine if their products are affected.
The recalled product
- Product
- AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
- 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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