Recall Z-1895-2009 ยท FHN Ligator, Hemorrhoidal
Boston Scientific Corporation
Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemos
| Date | Sep 2, 2009 (initiated Jun 17, 2009) |
| Status | Terminated |
| Reason | The clip may not deploy or, if deployed, the clip may not release from the tissue. |
| Root cause | Process control |
| Action | Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance. |
| Quantity | 217 |
| Distribution | Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040148 | RESOLUTION HEMOSTASIS CLIPPING DEVICE Boston Scientific Corp, Apr 22, 2004 |