Device product
Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
Z-1430-2023
Product summary
- Event
- Event 91968
- Status
- Ongoing
- Classification
- Class II
- Quantity
- ME754: 3 units; ME764: 22 units
- Official record key
device-enforcement:Z-1430-2023
Official wording
Reason: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Code information: GUIDID: 04046955299592 (Basket Lid)
Distribution pattern: US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.
Derived failure modes
-
Labeling or packaging
Mislabeled