Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling AAMI 3 Non-Reinf 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 3/5 (High).
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, flora, particulates) where no specific illnesses or injuries are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns, Item Code 9545, in size XL. The recall involves 7,659,634 total units. The gowns are 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 source text does not specify reported illnesses or injuries associated with these products.
Healthcare facilities and consumers should stop using the affected gowns. Affected lot numbers follow specific formats for single-sterile and bulk non-sterile products manufactured in 2018 or 2019, with facility code 'J'. Users should check their inventory against the lot number formats provided in the official recall notice.
The recalled product
- Product
- AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
- 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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