Z-2097-2021 Class II Ongoing
FDA device recall Z-2097-2021 was initiated by Dutch Ophthalmic USA, Inc. on April 14, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 13 Boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- April 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 Boxes
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
Distribution Pattern
Nationwide Distribution in the states of CA, FL, MA, and UT.
Code Information
Lot Number(s) 039406 Unique Device Identifier (UDI) 08717872016122