Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length
FDA device recall Z-0583-2007 · posted 2007-03-08 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
- Action taken
- There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Quantity affected
- 17
- Distribution
- Illinois
- Date initiated
- 2007-01-02
- Date posted
- 2007-03-08
- Date terminated
- 2008-02-24
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |
| EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178) | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |