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U.S. Department of Health and Human Services

Class 2 Device Recall Dutch Ophthalmic Replacement Backflush Brush Needles

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 Class 2 Device Recall Dutch Ophthalmic Replacement Backflush Brush Needlessee related information
Date Initiated by FirmFebruary 25, 2021
Create DateJuly 19, 2021
Recall Status1 Terminated 3 on November 05, 2021
Recall NumberZ-2091-2021
Recall Event ID 88153
Product Classification Cannula, ophthalmic - Product Code HMX
ProductDisposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Code Information Lot Number(s) 3420011396 Unique Device Identifier (UDI) 08717872003757 
Recalling Firm/
Manufacturer		 Dutch Ophthalmic USA, Inc.
10 Continental Dr Bldg 1
Exeter NH 03833-7507
For Additional Information ContactSAME
603-778-6929
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Under Investigation by firm
ActionDutch 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.
Quantity in Commerce12 US
DistributionDistribution in US states of IL, IN, MO, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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