Recall Z-1210-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arter
| Date | Mar 25, 2010 (initiated Feb 18, 2010) |
| Status | Terminated |
| Reason | Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the catheter packaging (i.e. outer pouch side seal) of the affected products may be compromised. An undetected breach in sterility of the outer pouch may lead to contami |
| Root cause | Packaging |
| Action | Two "URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED" letters dated February 17, 2010 and February 18, 2010 were sent to the customers. The letters described the Action Description, Affected Product and Recall Instructions. The customers should immediately discontinue use of and remove all affected recalled product from your inventory, segregate the product in a secure location for return to Boston Scientific, complete and return the enclosed Account Reply Verification Tracking Form (even if you do not have any product to return) -fax to: Customer Service Call Center (866) 213 |
| Quantity | 99 |
| Distribution | Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963397 | ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER Boston Scientific Corp, Nov 25, 1996 |