Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the custom
FDA device recall Z-0808-05 · posted 2005-05-10 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly & had been sterilized, the ruptured seal breaches the sterility barrier for the package.
- Action taken
- US customers were sent certified letters beginning 03/25/05 identifying the situation, cautioning customers about the possibility of an open bag with loss of sterility and requested return of all product to Medtronic Perfusions Systems at 7611 Northland Blvd., Brooklyn Park, MN. Customers are also requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWE
- Distribution
- nationwide, Canada, Australia, Japan and Latin America
- Date initiated
- 2005-03-25
- Date posted
- 2005-05-10
- Date terminated
- 2005-11-17
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE (K896978) | Medtronic Vascular | 1990-02-28 |
| EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178) | Extracorporeal Medical Specialities, Inc. | 1980-02-21 |