Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
- Company
- Concentric Medical Inc
- Recall Initiated
- September 26, 2013
- Posted
- December 12, 2014
- Terminated
- December 8, 2014
- Recall Number
- Z-0525-2015
- Quantity
- 87 units
- Firm Location
- Mountain View, CA
Reason for Recall
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
Distribution
US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
Lot / Code Info
Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
Root Cause
Labeling mix-ups
Action Taken
The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via Fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, complete form even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.