Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the us
FDA device recall Z-0340-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
- Action taken
- An Important Customer Notification, dated 09/06/06, was sent to affected customers. The letter identifies the affected model and lot numbers. Medtronic requests that affected product be returned. A suplemental pack can be built and shipped to the customer upon request. Medtronic will replace all returned product. A Recall Certificate is asked to be completed by customer and faxed to Medtronic.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 146
- Distribution
- Distributed in 6 states: CA, FL, IL, IN, LA and TN
- Date initiated
- 2006-09-13
- Date posted
- 2007-01-25
- Date terminated
- 2007-02-03
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178) | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |