Recall Z-2091-2021 ยท HMX Cannula, Ophthalmic
Dutch Ophthalmic USA, Inc.
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
| Date | Feb 25, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | Dutch Opthalmic issued Urgent Medical Device Recall letter on 2/25/21 stating reason for recall, health risk and action to take: We request that you take the following immediate actions: Verify whether you have unused boxes or individual blisters of LOT 3420011396 in your inventory and quarantine product subject to this reca ll. Contact Customer Service at our distributor 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 the unused affected product. Complete the attached Device Recall Reconciliation Fo |
| Quantity | 12 US |
| Distribution | Distribution in US states of IL, IN, MO, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.