Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch
FDA device recall Z-1802-2010 · posted 2010-06-14 · Terminated
Recall details
- Recalling firm
- Medtronic CardioVascular
- Reason for recall
- Mislabeling-- The incorrect Instructions for use may have been included with this product.
- Action taken
- The firm, Medtronic, Inc., sent an "URGENT- VOLUNTARY MEDICAL DEVICE RECALL" dated July 30, 2009, to custumers (Sales Representatives, to health care provider, patient, and risk manager, hospital administrator). The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to immediately segregate any Racer Biliary units from model number XD518YF (L#0000705315) in their possession to prevent inadvertent use. Medtronic, Inc., representative will contact the customer to review the labeling and retrieve the device should it be in their inventory. The customers are being ask to cooperate by providing the representative with access to the product. If you have any questions, please contact 707-566-1548.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 13
- Distribution
- Worldwide distribution: USA and Greater China.
- Date initiated
- 2009-07-30
- Date posted
- 2010-06-14
- Date terminated
- 2011-01-31
- Location
- Santa Rosa, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) (K032768) | Medtronic Ave, Inc. | 2003-10-09 |