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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic

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  Class 3 Device Recall Medtronic see related information
Date Initiated by Firm April 06, 2007
Date Posted May 22, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-0817-2007
Recall Event ID 37852
510(K)Number Digitrapper-K981733  
Product Classification Buffer Solution - Product Code JCC
Product Medtronic Buffer Solution pH 1.07 500ml
REF 9012D1071
Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark
Code Information Lot #2610596
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
FDA Determined
Cause 2		 Other
Action Customers were sent a recall notice, a customer detail sheet for this product lot, and a reply form to be used when returning the suspect bottles. Distributor was provided with a formatted templates to be used in recalling the supsect bottles from their customers and instructions on how to manage the returns and ship the bottles back to Medtronic.
Quantity in Commerce 238
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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