Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
What this means for you
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 (bioburden, flora, particulates) where no specific illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns (Item Code 90370NB) in size XL. The recall involves 7,659,634 total units that were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), Canada, Australia, and several other countries.
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 the exact nature of the contamination or report any specific illnesses or injuries associated with the product.
Healthcare facilities and consumers should stop using the affected gowns. Affected lots are identified by specific lot number formats for single-sterile and bulk non-sterile products manufactured in 2018 or 2019. Users should check their inventory against the lot number details provided in the official recall notice to determine if their products are affected.
The recalled product
- Product
- AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
- 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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