The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Pr
Summary
The FDA issued a Class II for The device is a 25-gauge infusion line that is part of 25-gauge surgical pack la by Dutch Ophthalmic USA, Inc.. Reason: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line.
Details
Source
Device Recall
External ID
Z-2252-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
Quantity Affected: 16 boxes
Reason for Recall
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
Distribution
US Nationwide Distribution in the states of AL, CA, CO, FL, MI
Type: Voluntary: Firm initiated
Recall Initiated: 2019-05-21
Company
Exeter, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Dutch Ophthalmic USA, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dutch Ophthalmic USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dutch Ophthalmic USA, Inc. have FDA actions?
Dutch Ophthalmic USA, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2252-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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