Recall Z-2097-2021— Dutch Ophthalmic USA, Inc.

Name: FDA recall Z-2097-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-14

Class II · Ongoing

Class II FDA medical device recall by Dutch Ophthalmic USA, Inc., initiated 2021-04-14. It names one FDA 510(k) clearance: K031023. Product: Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC. Reason: 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.

Recalling firm: Dutch Ophthalmic USA, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-04-14
Firm location: Exeter, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K031023 — PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10Peregrine Surgical , Ltd.·cleared 2003-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.