SmartGown Breathable Surgical Gowns recalled for packaging seal defects
Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.
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: This FDA Class II recall involves potential sterility compromise in surgical gowns due to open packaging seals. With no reported illnesses or injuries, the theoretical hazard in this risk-of-harm product scores as High per the rubric.
Plain-English summary
Cardinal Health is recalling 224,312 units of SmartGown Breathable Surgical Gowns with raglan sleeves (X-large, X-long, A-line, SKU 32474). The gowns were distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, and various countries in Latin America and the Caribbean.
The recall is due to the potential for open packaging seals. If packaging seals fail to remain intact, the surgical gowns could lose their sterility, which is critical since these gowns are used in surgical settings where maintaining sterility is essential to prevent surgical site infections.
Healthcare facilities that received affected lot numbers should inspect received gowns for packaging integrity before using them in surgical procedures. Affected lot numbers are: 20MFQ001, 20MFQ002, 20MFQ003, 21AFQ001, 21BFQ001, 21BFQ002, 21CFQ001, 21CFQ002, 21CFQ003, 21DFQ001, 21DFQ002, 21EFQ001, 21EFQ002, 21FFQ001, 21FFQ002, 21GFQ001, 21GFQ002, 21GFQ003, 21HFQ001, and 21JFQ001. Healthcare facilities should contact Cardinal Health for instructions on how to return or replace the affected gowns.
The recalled product
- Product
- SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 224,312
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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