FDA recall Z-2091-2021

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

Reason for recall

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

Distribution

Distribution in US states of IL, IN, MO, PA.

Key facts

Status

Terminated

Initiation date

2021-02-25

Report date

2021-07-28

Termination date

2021-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Exeter, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2021