SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Summary
The FDA issued a Class II for SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line by Cardinal Health. Reason: Potential for open packaging seals compromising the sterility of the surgical gowns.
Details
Source
Device Recall
External ID
Z-0368-2022
Action Date
2021-12-22
Status
Ongoing
Category
device
Product Description
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Lot/Code Info: Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Quantity Affected: 224,312 units
Reason for Recall
Potential for open packaging seals compromising the sterility of the surgical gowns
Distribution
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-02
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cardinal Health has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health have FDA actions?
Cardinal Health has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0368-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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