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 |
Product Classification |
Buffer Solution - Product Code JCC
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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
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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 |
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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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