Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
FDA device recall Z-0011-2008 · posted 2007-10-10 · Terminated
Recall details
- Recalling firm
- Pml Microbiologicals Inc.
- Reason for recall
- Marketed a regulated product without a 510(k).
- Action taken
- Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.
- Root cause
- PMA
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 1205 plates distributed in US; 1040 distributed in Canada
- Distribution
- US, Puerto Rico, & Canada
- Date initiated
- 2007-08-17
- Date posted
- 2007-10-10
- Date terminated
- 2011-06-07
- Location
- Wilsonville, OR
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