FDA Medical Device Recalls (openFDA)
Dutch Ophthalmic USA, Inc.: 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.
- Recall number
- Z-2252-2021
- Recalling firm
- Dutch Ophthalmic USA, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2019-05-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line
- Root cause
- 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
- 16 boxes
- Distribution
- US Nationwide Distribution in the states of AL, CA, CO, FL, MI
- Lot, serial or model codes
- Lot Number: 2000401997 Unique Device Identifier (UDI) 08717872021294
- 510(k) numbers
- ["K190875"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 3007916166
- Firm city
- Exeter
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28