Recalls / —
—#64554
Product
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
- FDA product code
- KRA — Catheter, Continuous Flush
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K000177
- Affected lot / code info
- Lot Numbers: 9218692; 9218628; 9218451
Why it was recalled
Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
Root cause (FDA determination)
Packaging process control
Action the firm took
Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2007-09-10
- Posted by FDA
- 2007-10-31
- Terminated
- 2007-12-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #64554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.