Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Pa
FDA device recall Z-2166-2008 · posted 2008-08-26 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
- Action taken
- Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- 67 Units
- Distribution
- International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
- Date initiated
- 2005-11-01
- Date posted
- 2008-08-26
- Date terminated
- 2008-09-10
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.