Dutch Ophthalmic USA, Inc. Recalls
Showing 1-3 of 3 recalls
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
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
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.
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019.
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
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
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 date of 2024- 10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. " For opened boxes of LOT 039406, verify that expiry dates in any hospital system are showing the correct expiry date of 2024-10-01. If not, please ensure the expiry date is modified to reflect the actual expiry date. Complete the attached Urgent Medical Device Safety Notice Reconciliation Form, sign it and return a scan or photo of the signed form by email to d.clement@dorcglobal.com. " Add the original completed and signed Urgent Medical Device Safety Notice Reconciliation Form referencing the Return Material Authorization number with the product to be returned. In the next days our sales representative will contact you to discuss replacement of the to be returned boxes and to verify whether there are additional questions or actions in which we can assist. If in the meantime you need any further information or support concerning this issue, please contact our local representative at Dutch Ophthalmic USA at 1-800-753-8824 x 1 for assistance.