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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 Form, sign it and return a scan or photo of the signed form by email to j.dearth@dorcqlobal.com. Add the original completed and signed Device Recall Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next few days a Service rep will contact you to discuss replacement of returned products. Contact Dutch Ophthalmic 1-800-753-8824 x1 for assistance.

Distribution

As reported by FDA

IL, IN, MO, PA