Recall Z-1319-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corporation
Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresecta
| Date | Mar 28, 2012 (initiated Mar 2, 2012) |
| Status | Terminated |
| Reason | Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton. |
| Root cause | Incorrect or no expiration date |
| Action | Boston Scientific sent a Urgent Medical Device Recall letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed to cease use, quarantine and return unused product with directions to forward the notification to the hospital level. Customers were directed to fill out the Reply Verification Tracking Form and fax to 5086835578, for reimbursement. Returned goods are to be sent to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, |
| Quantity | 682 (1555 used) |
| Distribution | USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053128 | SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE Boston Scientific Corp, Nov 30, 2005 |