Recall Z-1496-2009
Arrow International Inc · initiated February 11, 2009
Product
Arrow Two-Lumen Central Venous Access (MAC)
Codes / lots: All lots of Product codes listed in Z-1489-2009.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1496-2009
- Initiated
- February 11, 2009
- Posted by FDA
- June 24, 2009
- Terminated
- July 22, 2010
- Product code
- DYB – Introducer, Catheter
- 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…
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1489-2009 | Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits.Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1490-2009 | Arrow Extension sets and accessories for intravascular use.Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1491-2009 | Arrow Super Arrow-Flex Percutaneous Sheath IntroducersLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1492-2009 | Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath IntroducersLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1493-2009 | Arrow Percutaneous Sheath IntroducersLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1494-2009 | Arrow Single Lumen CVCs (Central Venous Catheters)Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1495-2009 | Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1497-2009 | Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1498-2009 | Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters)Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1499-2009 | Arrow ARROWg+ard CVCs (Central Venous Catheters)Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1500-2009 | Arrow Balloon and stylet temporary pacing catheterLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1501-2009 | Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis graftsLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1502-2009 | Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis graftsLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |
| Z-1503-2009 | Arrow Peripherally Inserted Central CatheterLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | 02/11/2009Terminated |