Merit Medical ReSolve Manual Del Usuario página 7

THIS IS AN URGENT PRODUCT RECALL / FIELD SAFETY NOTICE:
Reason for product retrieval:
Merit Medical Systems, Inc. is recalling all ReSolve
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.
Please provide status on the following:
Lot # Part # Qty
Qty Issue Send
Discarded Credit Replacements
** Merit Medical Customer Service Use Only
Please fill out and sign the Product Retrieval Form and complete the following steps. It is very important that you complete these steps in order to assist
Merit in complying with applicable government regulations.
1. Fax the completed Product Retrieval Form to: Jackie Preece 801-208-3378
2. Mail the completed Product Retrieval Form from (#1) above using the provided postage-paid, self-addressed envelope to Merit.
3. Place a copy of the signed completed Product Retrieval Form with the products to be returned as below. The form must accompany all products
being returned to Merit.
Product Return Instructions
Return the affected products by shipping them back to Merit via Federal Express 2
table above on the outside of the box and ship to:
If you have further questions, please contact: Jesse Hansen 801-826-4034
I certify that I received and understood this notice. I certify that the above listed products have been either: used, removed from inventory, discarded, or
returned to Merit Medical Systems, Inc. according to the notification instructions. Furthermore, if I have further distributed product listed on this form, I
certify that a copy of this notice was provided to said consignee(s).
___________________________________________________________
Signature of Site Representative
Urgent Field Safety Notice
Product Retrieval Form
Merit Medical Systems, Inc.
Address
® Locking Biliary Drainage Catheters (RBC & RBDC). Merit has become aware of one catheter failure during a routine
Mfg. Date Exp. Date Customer
PO #
Qty ** Sales Order #
RGA Department, RGA # (as applicable from table above)
Merit Medical Systems, Inc.
1600 West Merit Parkway, South Jordan, UT 84095-2416
Site Representative .
Title
Phone #
Date
Merit RGA Qty
Order # Used
** Ship Via Attention: _______________________________________
Department: _____________________________________
nd Day Air (Acct# 1129-5275-6), include the assigned RGA number from the
Attn: Richard Collard
Date ____________________________________________________
RECALL NOTIFICATION FORM
Qty On Hand Qty Being Date
& Unused Returned Returne
d
Shipment Tracking #
Form 9.034/D