Summary
The FDA issued a Class III for HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) by O&M HALYARD, INC.. Reason: Product was mislabeled as a Surgical Cap at its dispenser level..
Details
Source
Device Recall
External ID
Z-1461-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Lot/Code Info: Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Quantity Affected: 250 cases (75,000 pieces)
Reason for Recall
Product was mislabeled as a Surgical Cap at its dispenser level.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-20
Company
Mechanicsville, VA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (O&M HALYARD, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD, INC. have FDA actions?
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1461-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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