FDA Medical Device Recalls (openFDA)
Vitreq Bv: VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
- Recall number
- Z-0855-2020
- Recalling firm
- Vitreq Bv
- Product
- VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
- Status
- Terminated
- Initiated
- 2019-12-17
- Posted
- not on file
- Terminated
- 2020-12-09
- Reason
- Microscopic tears of the sterile pouch may compromise sterility
- Root cause
- Package design/selection
- Action
- VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account or complete the response form even if you do not have product to return.3.Return the Attachment 1: Response Form to BVI by one of these methods: Fax 866-906-4304 or email a copy to Claims_US@bvimedical.com. If you have any specific product replacement questions you may contact Customer Service Team at: Claims_US@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 3012037425
- Firm city
- Vierpolders
- Firm state
- not on file
- Firm country
- Netherlands
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