Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene oxide gas Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-2035 Use before 2007-01 UPN H7493892820350 Sterilized with ethylene oxide gas Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
FDA Recall Z-2166-2008 · Posted 2008-08-26
Advertisement
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLOX
Date Initiated2005-11-01
Date Terminated2008-09-10
Product Quantity67 Units
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.
Firm Action
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
Distribution Pattern
International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement