FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark
- Recall number
- Z-0817-2007
- 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
- Status
- Terminated
- Initiated
- 2007-04-06
- Posted
- 2007-05-22
- Terminated
- 2008-03-02
- Reason
- Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
- 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
- 238
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot #2610596
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JCC
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28