Summary
The FDA issued a Class II for RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 by Cardinal Health. Reason: Potential for open packaging seals compromising the sterility of the surgical gowns.
Details
Source
Device Recall
External ID
Z-0377-2022
Action Date
2021-12-22
Status
Ongoing
Category
device
Product Description
RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
Lot/Code Info: Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)
Quantity Affected: 9,990 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-0377-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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