Device product
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Z-2091-2021
Product summary
- Event
- Event 88153
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 US
- Official record key
device-enforcement:Z-2091-2021
Official wording
Reason: Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
Code information: Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757
Distribution pattern: Distribution in US states of IL, IN, MO, PA.
Derived failure modes
-
Labeling or packaging
Mislabeled