Recall Z-0331-2009 ยท FCG Biopsy Needle
Boston Scientific Corporation
Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas. UPN for inner pouch M001434530. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
| Date | Nov 28, 2008 (initiated Oct 7, 2008) |
| Status | Terminated |
| Reason | Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. |
| Root cause | Device Design |
| Action | Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated October 21, 2008. The letter was addressed to The Hospital Field Action Contact. The letter described the problem and products being recalled. The letter stated that it was very important that the attached product table be used carefully and consider both inner and outer packaging product codes when searching for affected/recalled product as the UPN numbers on the inner and outer labeling are different. Requested to discontinue use of product, identify, and segregate and return affected products to BSC. |
| Quantity | 3808 total for all products |
| Distribution | Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040893 | EASY CORE BIOPSY SYSTEM Boston Scientific Corp, May 6, 2004 |