Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing isc
FDA device recall Z-2598-2014 · posted 2014-09-08 · Terminated
Recall details
- Recalling firm
- Concentric Medical Inc
- Reason for recall
- Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NRY
- Quantity affected
- 9 devices
- Distribution
- US Distribution including the states of PA, CA, TX, NM, and OH.
- Date initiated
- 2014-06-25
- Date posted
- 2014-09-08
- Date terminated
- 2014-10-29
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO MERCI RETRIEVER (K082034) | Concentric Medical, Inc. | 2008-08-15 |