FDA recall Z-0650-2022
Merete Medical GmbH · Class II · device
Product
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
Domestic: Illinois; Foreign: Germany.
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-18
- Report date
- 2022-02-23
- Termination date
- 2023-02-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Berlin, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2022