Merit Medical ReSolve Manual Del Usuario

Danish Medicines Agency (DMA)
Axel Heides Gade 1, DK - 2300 - Kobenhavn,
DENMARK
Tel:+45 44 88 9595, fax:+45 44 88 9599
E-mail: med-udstyr@dkma.dk,
Web sites: www.medicinskudstyr.dk,
Date: 24-Jan-2013
SCOPE: Notification of Field Safety Corrective Action (FSCA) - Resolve Locking Biliary
Drainage Catheters
Merit Reference: 1721504-1/25/13-001-R
Dear Sir/Madam,
Merit Medical Systems, Inc. is voluntarily 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 was observed to be in several pieces under fluoroscopic visualization prior
to removal. Unused product must be quarantined immediately and returned to Merit. Merit
recommends that medical judgment be used in order to assess the risk-benefit of removing catheters
from patients. Merit also advises users to discontinue placement of any further devices. Merit has
received no reports of patient harm or injury resulting from this issue.
The products involved in the product retrieval are classified under the Medical Device Directive as:
BRAND NAME:
CLASSIFICATION:
CONFORMITY
ASSESSMENT ROUTE:
NOTIFIED BODY:
EC CERTIFICATE:
INTENDED USE:
AUTHORIZED
REPRESENTATIVE:
http://medicaldevices.dk/
ReSolve® Drainage Catheters
Class IIa sterile, rule 7, according to Annex IX of the Medical Device
Directive 93/42/EEC
Annex II, Section 3.2 of the EC Directive 93/42/EEC as amended by
Directive 2007/47/EC
BSI Product Services, Number 0086
CE 541900
The RBC and RBDC with locking pigtail and hydrophilic coating are used
for drainage of bile within the biliary system.
Merit Medical Ireland, Ltd.
Parkmore Business Park West
Galway, Ireland
Confidential Information
Contact: Mark Mullaney
Phone: +353-91-703-761
Fax: +353-91-771-888
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