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Terminated

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

FDA Recall Z-0869-2010 · Posted 2010-02-26

Recalling FirmMedtronic Inc
Recall StatusTerminated
Product CodeKRI
Date Initiated2009-12-14
Date Terminated2011-04-20
Product Quantity12

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

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

CA, CO, JAPAN, CHINA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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