FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Single Lumen CVCs (Central Venous Catheters)
- Recall number
- Z-1494-2009
- Recalling firm
- Arrow International Inc
- Product
- Arrow Single Lumen CVCs (Central Venous Catheters)
- Status
- Terminated
- Initiated
- 2009-02-11
- Posted
- 2009-06-24
- Terminated
- 2010-07-22
- Reason
- Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Root cause
- Device Design
- Action
- Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.
- Quantity
- 900,000 total, all products
- Distribution
- Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
- Lot, serial or model codes
- All lots of Product codes listed in Z-1489-2009.
- 510(k) numbers
- ["K820009"]
- PMA numbers
- not on file
- Product code
- DQY
- 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