Recalls / —
—#51946
Product
Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark
- FDA product code
- JCC — Ph Buffer
- Device class
- Class 1
- Medical specialty
- Pathology
- Affected lot / code info
- Lot #2610596
Why it was recalled
Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-04-06
- Posted by FDA
- 2007-05-22
- Terminated
- 2008-03-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #51946. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.