Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Summary
The FDA issued a Class II for Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only by Merete Medical GmbH. Reason: Incorrect marketing label (25 mm) was applied to product size 20 mm..
Details
Source
Device Recall
External ID
Z-0650-2022
Action Date
2022-02-23
Status
Terminated
Category
device
Product Description
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Lot/Code Info: Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816
Quantity Affected: 26 units
Reason for Recall
Incorrect marketing label (25 mm) was applied to product size 20 mm.
Distribution
Domestic: Illinois; Foreign: Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-18
Company
Berlin, 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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Merete Medical GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merete Medical GmbH have FDA actions?
This is the only FDA action we have on record for Merete Medical GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0650-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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