Medtronic Cardiovascular Revascularization & Surgical Therap Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and acc Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com

Recommended Action

Per FDA guidance

An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product. For further questions, contact Medtronic at 1-763-514-9605.

Distribution

As reported by FDA

AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, PA, TN, TX, WI