Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating
FDA device recall Z-1901-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the
- Action taken
- Boston Scientific issued an "Urgent Medical Device Recall -Immediate Action Required" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned. For further information, contact Boston Scientific at 1-508-683-6036.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 79 units (1 box = 1 unit)
- Distribution
- Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands.
- Date initiated
- 2009-07-01
- Date posted
- 2009-08-27
- Date terminated
- 2011-12-02
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIMA BILIARY CATHETER (K023870) | Boston Scientific/Medi-Tech | 2002-12-20 |