Cardinal Health Recalls AAMI 3 Surgical Gowns Due to 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 levels (bioburden, flora, particulates) which poses a risk of harm (infection) 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 Nonreinforced Surgical Gowns (Item Code 9515NB). The recall affects specific lots manufactured in 2018 and 2019, with distribution spanning the United States, Puerto Rico, Guam, and numerous international locations including Canada, Australia, and several countries in the Middle East and Latin America.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These contaminants pose a risk of infection or other adverse health effects to patients and healthcare workers using the gowns during surgical procedures.
Healthcare facilities and distributors should stop using the affected gowns immediately and contact Cardinal Health for instructions on returning the product. Consumers who have purchased these gowns should also cease use and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
- 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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