Recalls / —
—#125921
Product
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
- FDA product code
- DQY — Catheter, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K033441
- Affected lot / code info
- 2013040058
Why it was recalled
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.
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Scimed Pl, Maple Grove, Minnesota 55311-1565
Distribution
- Distribution pattern
- TX and Russia
Timeline
- Recall initiated
- 2014-03-03
- Posted by FDA
- 2014-03-10
- Terminated
- 2014-06-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125921. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.