Recall Z-0065-2020 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
| Date | Nov 13, 2018 |
| Status | Terminated |
| Reason | Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging |
| Root cause | Labeling False and Misleading |
| Action | On 11/13/2018, a "Urgent Medical Device Voluntary Field Corrective Action" letter was sent to all affected consignees. Per the customer notification letter, it informed customers of the following: 1. Immediately check your internal inventory for 9F BGC Lot 0000010779. 2. Circulate this Customer Communication internally to all interested/affected parties. 3. If the specified lot is located, open the carton and remove the pouch. Without removing the device from the pouch or breaking the sterile barrier, inspect the device through the pouch and confirm that the text on the white strain relief re |
| Quantity | 190 catheter guides |
| Distribution | OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland |
| FDA record | Open on fda.gov |