Recall Z-0817-2007 ยท JCC Ph Buffer
Medtronic Neuromodulation
Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark
| Date | May 22, 2007 (initiated Apr 6, 2007) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.