Recall Z-0764-2022 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
| Date | Dec 22, 2021 |
| Status | Open, Classified |
| Reason | Sterility of device is compromised due to a sterile barrier breach |
| Root cause | Packaging process control |
| Action | BSC issued Urgent Medical Device Product Removal - Immediate Action Required on December 16, 2021. Letter states reason for recall, health risk and action to take: The Reply Verification Tracking Form enclosed with this letter must be completed and returned even if you do not have any product from the affected lot/batches. 1. Immediately discontinue use of and segregate affected product. " Immediately remove all affected product from your inventory. " Segregate this product in a secure location for return to Boston Scientific. 2. You must complete and email or fax your Reply Verification Tra |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013153 | AUTOTOME RX MODEL # 4515, 4516 Boston Scientific Corp, Oct 19, 2001 |