Date Initiated by Firm | May 21, 2019 |
Create Date | August 12, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2252-2021 |
Recall Event ID |
88162 |
510(K)Number | K190875 |
Product Classification |
Unit, phacofragmentation - Product Code HQC
|
Product | 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. |
Code Information |
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294 |
Recalling Firm/ Manufacturer |
Dutch Ophthalmic USA, Inc. 10 Continental Dr Bldg 1 Exeter NH 03833-7507
|
For Additional Information Contact | 603-778-6929 |
Manufacturer Reason for Recall | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Dutch Ophthalmic Customers were contacted via their sales representative of the issue and then sent replacement infusion lines o/a June 28, 2019. |
Quantity in Commerce | 16 boxes |
Distribution | US Nationwide Distribution in the states of AL, CA, CO, FL, MI |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HQC
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