Z-0650-2022 Class II Terminated
FDA device recall Z-0650-2022 was initiated by Merete Medical GmbH on January 18, 2022 and is designated Class II. Reason for recall: Incorrect marketing label (25 mm) was applied to product size 20 mm. The recall status is terminated (terminated February 16, 2023). Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 23, 2022
- Initiation Date
- January 18, 2022
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Reason for Recall
Incorrect marketing label (25 mm) was applied to product size 20 mm.
Distribution Pattern
Domestic: Illinois; Foreign: Germany.
Code Information
Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816