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Terminated

Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

FDA Recall Z-0011-2008 · Posted 2007-10-10

Recalling FirmPml Microbiologicals Inc.
Recall StatusTerminated
Product CodeJSO
Date Initiated2007-08-17
Date Terminated2011-06-07
Product Quantity1205 plates distributed in US; 1040 distributed in Canada

Reason for Recall

Marketed a regulated product without a 510(k).

Firm Action

Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.

Root Cause

PMA

Distribution Pattern

US, Puerto Rico, & Canada

Official Source

View FDA Recall →

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

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