Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlun
FDA device recall Z-0817-2007 · posted 2007-05-22 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JCC
- Quantity affected
- 238
- Distribution
- Nationwide.
- Date initiated
- 2007-04-06
- Date posted
- 2007-05-22
- Date terminated
- 2008-03-02
- Location
- Minneapolis, MN
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