Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & D
FDA device recall Z-0813-2012 · posted 2012-01-18 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Reason for recall
- Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
- Action taken
- Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 106
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Be
- Date initiated
- 2011-12-14
- Date posted
- 2012-01-18
- Date terminated
- 2014-05-22
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |