Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 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.
This recall has been terminated (originally issued June 6, 2011).
- Company
- Terumo Medical Corporation
- Recall Initiated
- June 24, 2010
- Posted
- June 6, 2011
- Terminated
- July 7, 2011
- Recall Number
- Z-2415-2011
- Quantity
- 214 units
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Molding defect in destination product that render the device unusable.
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
Lot / Code Info
RSC01
Root Cause
Equipment maintenance
Action Taken
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 manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.