Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
This recall has been terminated (originally issued November 13, 2018).
- Company
- Stryker Neurovascular
- Recall Initiated
- November 13, 2018
- Terminated
- August 3, 2020
- Recall Number
- Z-0065-2020
- Quantity
- 190 catheter guides
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Distribution
OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
Lot / Code Info
Lot number 0000010779; This lot was not distributed within the US
Root Cause
Labeling False and Misleading
Action Taken
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 reads 9F/.085 ID (shown in Fig. 1). If confirmed, no further action is needed to be taken for this device. 4. If the device identified above reads 8F/.078 ID (shown in Fig. 2) please discard the device and take note of this in the comments section in the attached response form. 5. On receipt of this form, replacement product will be issued to you. If you require assistance in executing these steps, please reach out to your Stryker sales representative. 6. Inform Stryker if any of the subject devices have been distributed to other organizations and provide Stryker the contact information for these organizations. 7. Please inform Stryker of any adverse events concerning the use of the subject devices. 8. Return the completed form to NVFieldActions@stryker.com. 9. We request that you respond to this notice within 7 calendar days from the date of receipt. The target date for completion of this action is 31 Jan 2019 and your timely response will enable us to ensure that we meet this target.