Recall Z-2097-2021 ยท HQF Laser, Ophthalmic
Dutch Ophthalmic USA, Inc.
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
| Date | Apr 14, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| Action | Dutch Ophthalmic issued Urgent Medical Device Recall letter on 4/14/21 via Certified Mail. Letter states reason for recall, health risk and action to take: Verify whether you have unused boxes of LOT 039406 in your inventory and quarantine product subject to this safety notice. " If returned contact Customer Service at Dutch Ophthalmic, USA at 1-800-753- 8824 x 1 to receive a Return Material Authorization (RMA) number and receive instructions on how to return unused boxes of the impacted product. " If not returning, verify that expiry dates in any hospital system are showing the correct expiry |
| Quantity | 13 Boxes |
| Distribution | Nationwide Distribution in the states of CA, FL, MA, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 Peregrine Surgical , Ltd., Jun 27, 2003 |