FDA recall Z-2097-2021

Dutch Ophthalmic USA, Inc. · Class II · device

Product

Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

Reason for recall

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

Distribution

Nationwide Distribution in the states of CA, FL, MA, and UT.

Key facts

Status
Ongoing
Initiation date
2021-04-14
Report date
2021-07-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Exeter, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2097-2021