Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Gui
FDA device recall Z-2417-2011 · posted 2011-06-06 · Terminated
Recall details
- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- Molding defect in destination product that render the device unusable.
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 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
- Date initiated
- 2010-06-24
- Date posted
- 2011-06-06
- Date terminated
- 2011-07-07
- Location
- Elkton, MD
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENAL GUIDING SHEATH (K012854) | Terumo Medical Corp. | 2001-11-21 |