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Terminated

Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken 16-18 DK-2740 Skovlunde, Denmark

FDA Recall Z-0817-2007 · Posted 2007-05-22

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeJCC
Date Initiated2007-04-06
Date Terminated2008-03-02
Product Quantity238

Reason for Recall

Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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