—#88089

Product

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

FDA product code: KRI — Accessory Equipment, Cardiopulmonary Bypass
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: Lot #: 1093645, 1102929, 1139554

Why it was recalled

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 (FDA determination)

Incorrect or no expiration date

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: CA, CO, JAPAN, CHINA.

Timeline

Recall initiated: 2009-12-14
Posted by FDA: 2010-02-26
Terminated: 2011-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88089. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.