Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the
FDA device recall Z-0030-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
- Action taken
- Recall letter was sent to customers on 6/20/2006 by US mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- NVM
- Quantity affected
- 11 units
- Distribution
- Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.
- Date initiated
- 2006-06-20
- Date posted
- 2006-10-12
- Date terminated
- 2006-10-16
- Location
- Reading, PA
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