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.
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 medical device with unknown contamination levels (bioburden and particulates), which poses a risk of harm, 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 FABREINF SCRUB SURG GWN L NS surgical gowns (Item Code 90970NA). 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 product was 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. The source text does not specify the exact nature of the contaminants or report any specific illnesses or injuries associated with the use of these gowns.
Healthcare facilities and consumers should check their inventory for the affected lot numbers and stop using the recalled gowns. The source text does not provide specific instructions for disposal or return, but users should follow standard protocols for handling potentially contaminated medical devices.
The recalled product
- Product
- AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
- 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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