Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination
Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns (4XL) 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk scenarios like unknown contamination in sterile medical devices are classified as Severe (Score 4).
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 Nonreinforced Surgical Gowns, size 4XL (Item Code 9599). The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
The affected products were distributed worldwide, including in 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 covers specific lot numbers manufactured in 2018 and 2019, identified by specific alphanumeric formats and facility codes.
Healthcare facilities and consumers should stop using the affected gowns immediately. Users should check their inventory for the specific lot numbers and formats described in the recall notice. Cardinal Health is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
- 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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