Z-0869-2010

ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604

Name: Z-0869-2010 ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604
Creator: Medtronic Inc
Published: 2009-12-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-12-14 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc began a recall of ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604 on 2009-12-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0869-2010
Status: Terminated
Initiated: 2009-12-14
Posted: 2010-02-26
Terminated: 2011-04-20
Recalling firm: Medtronic, Inc.
Product: ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
Product code: KRI Accessory Equipment, Cardiopulmonary Bypass
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 12
Distribution: CA, CO, JAPAN, CHINA.
Product codes and lots: Lot #: 1093645, 1102929, 1139554

Product code KRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)