Recall Z-1611-2013 ยท DYB Introducer, Catheter
Terumo Medical Corporation
Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
| Date | Jun 27, 2013 (initiated May 30, 2013) |
| Status | Terminated |
| Reason | Medical devices were incorrectly labeled with extended expiration dates. |
| Root cause | Error in labeling |
| Action | The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement. |
| Quantity | 20 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp., May 29, 2009 |