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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Custom Kits

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 Class 2 Recall
Medtronic Custom Kits
see related information
Date Posted July 13, 2009
Recall Status1 Open
Recall Number Z-1550-2009
Recall Event ID 51785
Product Classification Cardiopulmonary Bypass Catheter Kit - Product Code OEU
Product Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
Code Information Lot Numbers: 0000574290, 0000574314, 0000574316, 0000580205, 0000608559, 0000618615, 0000640122, 0000640634, 0000771456, 0000772227, 0000777567, 0000780964, 0000781651, 0000800394, 0000920163, 0000739503 and 0000950662.
Recalling Firm/
Manufacturer
Medtronic Cardiovascular Revascularization & Surgical Therap
7611 Northland Dr N
Brooklyn Park, Minnesota 55428-1088
Manufacturer 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
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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