Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Manufacturer: Medtronic , Inc. Minneapolis, MN 55432-5604 USA
FDA Recall Z-0808-05 · Posted 2005-05-10
Advertisement
Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWE
Date Initiated2005-03-25
Date Terminated2005-11-17
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.
Firm Action
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
Distribution Pattern
nationwide, Canada, Australia, Japan and Latin America
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement