Merit Medical ReSolve Manual Del Usuario página 5

Confidential Information
January xx, 2013
URGENT FIELD SAFETY NOTICE
Address and contact details
®
Product: Merit ReSolve Locking Biliary Drainage Catheter
Product Numbers: See attached Product Retrieval Form
Lot Number: See attached Product Retrieval Form
Dear contact name,
This letter is to inform you that Merit Medical Systems, Inc. is recalling all ReSolve Locking
Biliary Drainage Catheters (RBC & RBDC). Merit has become aware of one catheter failure
during a routine 90-day catheter replacement. The catheter tip was observed to be in several
pieces under fluoroscopic visualization prior to removal. Unused product must be quarantined
immediately and returned to Merit. Do not distribute these devices further. Merit recommends
that medical judgment be used in order to assess the risk-benefit of removing catheters from
patients. Merit has received no reports of patient harm or injury resulting from this issue.
Our records indicate that you have received ReSolve Locking Biliary Drainage Catheters (RBC
& RBDC) as noted on the attached Product Retrieval Form.
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