Recall Z-2417-2011 ยท DYB Introducer, Catheter
Terumo Medical Corporation
Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
| Date | Jun 6, 2011 (initiated Jun 24, 2010) |
| Status | Terminated |
| Reason | Molding defect in destination product that render the device unusable. |
| Root cause | Equipment maintenance |
| Action | Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally |
| Quantity | 7 units |
| Distribution | Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012854 | RENAL GUIDING SHEATH Terumo Medical Corp., Nov 21, 2001 |