Recall Z-1500-2009 ยท LDF Electrode, Pacemaker, Temporary
Arrow International Inc
Arrow Balloon and stylet temporary pacing catheter
| Date | Jun 24, 2009 (initiated Feb 11, 2009) |
| Status | Terminated |
| 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, Lat |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960479 | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc., Oct 17, 1996 |