FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
- Recall number
- Z-0030-2007
- Recalling firm
- Arrow International Inc
- Product
- Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.
- Status
- Terminated
- Initiated
- 2006-06-20
- Posted
- 2006-10-12
- Terminated
- 2006-10-16
- Reason
- The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
- Root cause
- Other
- Action
- Recall letter was sent to customers on 6/20/2006 by US mail.
- Quantity
- 11 units
- Distribution
- Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
- Lot, serial or model codes
- MF5124329
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NVM
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- 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