X
Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
N
ational
C
enter for
M
edical
D
evices
R
eporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home
Published FSNs/Recalls
About NCMDR
Contact Us
FAQ
Login
NCMDR Recall
Back
Reference Number:
mdprc 094 06 18 000
Date submitted:
6/27/2018
Manufacturer:
Stryker Neurovascular
Device Type:
SYNCHRO
Description:
Guidewires
Medical Device Identifier:
UPN CODE: M00326010, M00326110, M00326310, M00326320, M00326410, M00326420, M00326510, M00326520
All Lots manufactured from 02 October 2017 to 01 June 2018. All lots manufactured after this date have the correct dimension listed.
Reason of Field Safety Corrective Action:
Stryker Neurovascular has become aware that the product labels (pouch and carton) for Synchro 2 products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Remedy Action:
1. Immediately check your internal inventory.
2. Review the Communication and ensure full understanding of the contents.
3. Circulate this Customer Communication internally to all interested/affected parties.
4. Inform Stryker if any of the subject devices have been distributed to other organizations.
5. Please provide contact details so that Stryker can inform the recipients appropriately.
6. Please inform Stryker of any adverse events concerning the use of the subject devices.
7. Return the completed form to your nominated Sales Representative or to NVFieldActions@stryker.com.
Athorized Representative/Importer/Distributor:
FAROUK, MAAMOUN TAMER & COMPANY
Report Source:
NCMDR
Source Ref. Number:
700B0627B715F
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Stryker Neurovascular.pdf
View History
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.