Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Summary
The FDA issued a Class II for Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgi by Ansell Healthcare Products LLC. Reason: Transport company failed to stop at the border for required FDA inspection..
Details
Source
Device Recall
External ID
Z-0838-2022
Action Date
2022-04-06
Status
Ongoing
Category
device
Product Description
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Lot/Code Info: Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604
Quantity Affected: 74 cases
Reason for Recall
Transport company failed to stop at the border for required FDA inspection.
Distribution
U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-19
Company
Reno, NV
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 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ansell Healthcare Products LLC has 6 FDA actions in our database, including 3 recalls and 3 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 (Ansell Healthcare Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ansell Healthcare Products LLC have FDA actions?
Ansell Healthcare Products LLC has 6 FDA actions in our database, including 3 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0838-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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