Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits a

FDA device recall Z-1550-2009 · posted 2009-07-13 · Terminated

Recall details

Recalling firm

Medtronic Cardiovascular Revascularization & Surgical Therap

Reason for recall

Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com

Action taken

An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product. For further questions, contact Medtronic at 1-763-514-9605.

Root cause

Packaging process control

Status

Terminated

Product code

OEU

Quantity affected

1363 kits total (1215 US, 148 OUS)

Distribution

Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.

Date initiated

2009-03-23

Date posted

2009-07-13

Date terminated

2012-05-22

Location

Brooklyn Park, MN