HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Summary
The FDA issued a Class II for HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL by O&M HALYARD INC. Reason: All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing..
Details
Source
Device Recall
External ID
Z-0317-2022
Action Date
2021-12-08
Status
Ongoing
Category
device
Product Description
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Lot/Code Info: All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630
Quantity Affected: 2,928 cases (5,856,000 gloves)
Reason for Recall
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Distribution
Worldwide distribution - US Nationwide and the countries of EU/Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-27
Company
Alpharetta, GA
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 131 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 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 (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-0317-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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