Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 non-reinforced 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 levels (bioburden, flora, particulates) which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 non-reinforced surgical gowns (Item Code 9575EL). The recall affects gowns manufactured in 2018 and 2019 and distributed worldwide, including the United States, Puerto Rico, Guam, and various international markets.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These contaminants pose a potential risk of infection or other adverse health consequences to patients and healthcare workers.
Healthcare facilities and distributors should stop using the affected gowns immediately. Consumers and medical professionals should check their inventory for the specific lot numbers and formats described in the recall notice to identify affected units.
The recalled product
- Product
- AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
- 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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