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

FDA device recall Z-0869-2010 · posted 2010-02-26 · Terminated

Recall details

Recalling firm

Medtronic Inc

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

Action taken

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

Status

Terminated

Product code

KRI

Quantity affected

12

Distribution

CA, CO, JAPAN, CHINA.

Date initiated

2009-12-14

Date posted

2010-02-26

Date terminated

2011-04-20

Location

Minneapolis, MN