Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling specific lots of AAMI 3 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 high-risk product (surgical gowns) with a risk of harm (infection/injury) due to unknown contamination, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 FABRNF SCRUB SURG GWN XL NS surgical gowns (Item Code 91070NB). The recall affects specific lots manufactured in 2018 and 2019, identified by lot numbers ending in J or JX, or specific bulk non-sterile lot formats. The products were distributed worldwide, including the United States, Puerto Rico, Guam, and several 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 risk of infection or injury to patients and healthcare workers if the gowns are used in surgical settings.
Healthcare facilities and distributors should stop using and quarantine the affected gowns. Consumers and medical professionals should check their inventory against the specific lot number formats provided in the official recall notice to determine if they possess affected units.
The recalled product
- Product
- AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
- 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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