Recall Z-1671-2013
Boston Scientific Corporation · initiated May 28, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Lot/Batch Number: 091541
Reason for recall
Product labeled with incorrect expiration date.
FDA-determined cause: Incorrect or no expiration date
Action taken
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 not respond. For questions contact your local Sales Representative.
Details
- Recall number
- Z-1671-2013
- Initiated
- May 28, 2013
- Posted by FDA
- July 10, 2013
- Terminated
- February 10, 2014
- Product code
- KNQ – Dilator, Esophageal
- 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.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA