Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
FDA device recall Z-1164-2014 · posted 2014-03-10 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
- Action taken
- Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal " letter dated March 3, 2014. The letter described the problem and the product involved in the recall. The letter advised consignees to return the affected product and to complete and return the Account Reply Verification Tracking Form. The local Sales Representative can answer any questions that you may have regarding this Recall Removal.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 7
- Distribution
- TX and Russia
- Date initiated
- 2014-03-03
- Date posted
- 2014-03-10
- Date terminated
- 2014-06-09
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER (K033441) | Boston Scientific Corp | 2003-11-21 |