Z-2598-2014 Class II Terminated
FDA device recall Z-2598-2014 was initiated by Concentric Medical Inc on June 25, 2014 and is designated Class II. Reason for recall: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date. The recall status is terminated (terminated October 29, 2014). Affected quantity: 9 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2014
- Initiation Date
- June 25, 2014
- Termination Date
- October 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 devices
Product Description
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Reason for Recall
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
Distribution Pattern
US Distribution including the states of PA, CA, TX, NM, and OH.
Code Information
Model Number 90109; Lot number 35695