Recall Z-0639-04 ยท MPB Catheter, Hemodialysis, Non-Implanted
Arrow International Inc
Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
| Date | Jul 20, 2004 (initiated Feb 18, 2004) |
| Status | Terminated |
| Reason | catheter slips out of the suture wing during use. |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 2/18/04 to their direct accounts informing them of the problem and the need to return the product. |
| Quantity | 6610 UNITS |
| Distribution | The product was shipped to hospitals, medical supply companies, and sales representatives nationwide. Products were also shipped to England, Belgium, Germany, Greece, Sweden, Ukraine, France, Taiwan, Australia, Netherlands, and Denmark. |
| FDA record | Open on fda.gov |