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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the presence of unknown bioburden and microbiological flora in surgical gowns represents a significant risk of injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns, Item Code 9575, in size XXL. 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 agency has classified this as a Class II recall. Specific lot numbers are identified by formats including XXXXJXXX and YYMRJXXX for single-sterile lots, and XXXYRPQ for bulk non-sterile lots, with facility code J and production dates in 2018 or 2019.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on return or disposal. The source text does not specify a particular consumer action beyond the general recall notice.
The recalled product
- Product
- AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
- 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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