Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (surgical gowns) with unknown contamination levels where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.
Plain-English summary
Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns (Item Code 9541NA) due to the presence of an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall involves 7,659,634 total units.
The affected gowns were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia. Specific lot numbers are identified by formats such as XXXXXJ or XXXXXJX, or specific single-sterile and bulk non-sterile lot structures involving facility code J and production dates from 2018 or 2019.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on return or disposal. The FDA has classified this as a Class II recall.
The recalled product
- Product
- AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
- 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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