Z-0817-2007

Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18...

Name: Z-0817-2007 Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18...
Creator: Medtronic Neuromodulation
Published: 2007-04-06
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2007-04-06 / Terminated

FDA source

Medtronic Neuromodulation began a recall of Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark on 2007-04-06. The reason FDA records is "Medtronic pH 1.07 buffer solution lot #2610596 was mislableled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0817-2007
Status: Terminated
Initiated: 2007-04-06
Posted: 2007-05-22
Terminated: 2008-03-02
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark
Product code: JCC Ph Buffer
Reason for recall: Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
FDA root cause: 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.
Product codes and lots: Lot #2610596

Product code JCC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)