Recall Z-2598-2014
Concentric Medical Inc · initiated June 25, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model Number 90109; Lot number 35695
Reason for recall
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
FDA-determined cause: Process control
Action taken
Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.
Details
- Recall number
- Z-2598-2014
- Initiated
- June 25, 2014
- Posted by FDA
- September 8, 2014
- Terminated
- October 29, 2014
- Product code
- NRY – Catheter, Thrombus Retriever
- Quantity
- 9 devices
- Distribution
- US Distribution including the states of PA, CA, TX, NM, and OH.
- Recalling firm
- Concentric Medical Inc, Mountain View, CA