Summary
The FDA issued a Class II for CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 by Richard Wolf GmbH. Reason: Product labeled as Cutting Electrode may contain BIVAP electrode..
Details
Source
Device Recall
External ID
Z-2246-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Lot/Code Info: Lot Number 21002858
Quantity Affected: 20 boxes
Reason for Recall
Product labeled as Cutting Electrode may contain BIVAP electrode.
Distribution
US Nationwide Distribution in the states of CA, CO, IN, MA, NH
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-25
Company
Knittlingen, N/A
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 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Richard Wolf GmbH has 6 FDA actions in our database, including 6 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 (Richard Wolf GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Richard Wolf GmbH have FDA actions?
Richard Wolf GmbH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2246-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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