Recall Z-1612-2013 ยท DYB Introducer, Catheter
Terumo Medical Corporation
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
| 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 | 550 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102008 | GLIDESHEATH Terumo Medical Corp., Jul 21, 2010 |