Recall Z-1393-2012 ยท KOD Catheter, Urological
Boston Scientific Corporation
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Im
| Date | Apr 11, 2012 (initiated Mar 15, 2012) |
| Status | Terminated |
| Reason | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. This interaction was found to cause pi |
| Root cause | Package design/selection |
| Action | Boston Scientific sent an " Urgent Medical Device Recall" letter dated March 14. 2012. the letter was addressed to "Dear Risk/Materials Manager. The letter described the problem and the product involved in the recall. Advised consignees to cease the distribution of any remaining unused product affected. Advised distributors that the recall notification should be forwarded to their customers. Requested consignees to complete and return the Reply Verification tracking Form enclosed by fax to 508-683-5578. For questions regarding this recall 763-494-1700. Recall Expanded 4/24/12: Imager II A |
| Quantity | 11,340 (8,485 USA, 2,845 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finl |
| FDA record | Open on fda.gov |