Summary
The FDA issued a Class II for HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 by Devicor Medical Products Inc. Reason: Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the sma.
Details
Source
Device Recall
External ID
Z-1124-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Lot/Code Info: UDI-DI: 00841911102472 Lot F12201281D
Quantity Affected: 90 devices
Reason for Recall
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Distribution
US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-30
Company
Cincinnati, OH
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 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Devicor Medical Products Inc has 8 FDA actions in our database, including 2 recalls and 6 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 (Devicor Medical Products Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Devicor Medical Products Inc have FDA actions?
Devicor Medical Products Inc has 8 FDA actions in our database, including 2 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1124-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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