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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 Medtronicsee related information
Date Initiated by FirmApril 06, 2007
Date PostedMay 22, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall NumberZ-0817-2007
Recall Event ID 37852
Product Classification Buffer Solution - Product Code JCC
ProductMedtronic 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
ActionCustomers 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 Commerce238
DistributionNationwide.
Total Product Life CycleTPLC 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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