Z-0065-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- November 13, 2018
- Termination Date
- August 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 catheter guides
Product Description
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Reason for Recall
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Distribution Pattern
OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
Code Information
Lot number 0000010779; This lot was not distributed within the US