RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific
FDA device recall Z-1671-2013 · posted 2013-07-10 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Product labeled with incorrect 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- KNQ
- Quantity affected
- 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.
- Date initiated
- 2013-05-28
- Date posted
- 2013-07-10
- Date terminated
- 2014-02-10
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (K050232) | Boston Scientific Corp | 2005-03-11 |