Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 Royalsilk 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant potential hazards like unknown contamination in medical devices, even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Cardinal Health is recalling specific lots of AAMI 3 Royalsilk Surgical Gowns (Item Code 9518NC). The recall involves 7,659,634 total units that were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), Canada, Australia, and several other countries.
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. Affected lot numbers follow specific formats for single-sterile and bulk non-sterile products, generally involving manufacturing dates in 2018 or 2019 from facility code J.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions or a refund. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
- 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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