Device product
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Z-0065-2020
Product summary
- Event
- Event 83735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 catheter guides
- Official record key
device-enforcement:Z-0065-2020
Official wording
Reason: Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Code information: Lot number 0000010779; This lot was not distributed within the US
Distribution pattern: OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
Derived failure modes
-
Labeling or packaging
Labeling error