Recalls / —
—#156048
Product
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
- FDA product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Lot Number: 19343209 Exp: 6/3 0/2018
Why it was recalled
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Root cause (FDA determination)
Employee error
Action the firm took
Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification 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. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 BSCFieldActionCenter@bsci.com.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234
Distribution
- Distribution pattern
- MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Timeline
- Recall initiated
- 2017-06-01
- Terminated
- 2018-06-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #156048. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.