Medtronic Inc IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
Brand
Medtronic Inc
Lot Codes / Batch Numbers
Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369.
Products Sold
Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369.
Medtronic Inc is recalling IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfu due to Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components inclu
Recommended Action
Per FDA guidance
Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO
Page updated: Jan 10, 2026