Recall Z-1671-2013 ยท KNQ Dilator, Esophageal
Boston Scientific Corporation
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
| Date | Jul 10, 2013 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | Product labeled with incorrect expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | Boston Scientific sent an Urgent: Medical Device Recall letter to all affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The letter also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Follow-up communications will be made to the accounts that do no |
| Quantity | 91 |
| Distribution | Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050232 | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR Boston Scientific Corp, Mar 11, 2005 |