The device is a 25-gauge infusion line that is recall
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.
Why was The device is a 25-gauge infusion line that is recalled?
Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
- 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.
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- Quantity
- 16 boxes
- Distribution
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)