FDA Medical Device Recalls (openFDA)
MEDDEV USA, INC.: 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.
- Recall number
- Z-1625-2012
- Recalling firm
- MEDDEV USA, INC.
- Product
- 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.
- Status
- Terminated
- Initiated
- 2012-05-10
- Posted
- 2012-05-17
- Terminated
- 2013-08-15
- Reason
- The device was marketed without a 510(k) and is not sterile.
- Root cause
- No Marketing Application
- Action
- MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559.
- Quantity
- 20 units
- Distribution
- Nationwide Distribution including Illinois
- Lot, serial or model codes
- Lot 120493
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDH
- Firm FEI
- 3009257101
- Firm city
- Dallas
- Firm state
- TX
- 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