Summary
The FDA issued a Class II for VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS by Stradis Healthcare. Reason: Potential for incomplete seals..
Details
Source
Device Recall
External ID
Z-1688-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Lot/Code Info: Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
Quantity Affected: 520 units
Reason for Recall
Potential for incomplete seals.
Distribution
Pennsylvania
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-10
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 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stradis Healthcare 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 (Stradis Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stradis Healthcare have FDA actions?
Stradis Healthcare 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-1688-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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