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U.S. Department of Health and Human Services

Class 2 Device Recall Brain Heart Infusion Agar (BHIA)

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  Class 2 Device Recall Brain Heart Infusion Agar (BHIA) see related information
Date Initiated by Firm August 17, 2007
Date Posted October 10, 2007
Recall Status1 Terminated 3 on June 07, 2011
Recall Number Z-0011-2008
Recall Event ID 39367
Product Classification Microbiological media plates - Product Code JSO
Product Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML
Microbiological media plates
Code Information PML's catalog #P1174, LOT CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1, 237378-1, 237917-1
Recalling Firm/
Manufacturer		 Pml Microbiologicals Inc.
27120 Sw 95th Ave
P.o. Box 570
Wilsonville OR 97070
For Additional Information Contact
503-570-2500
Manufacturer Reason
for Recall		 Marketed a regulated product without a 510(k).
FDA Determined
Cause 2		 PMA
Action Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.
Quantity in Commerce 1205 plates distributed in US; 1040 distributed in Canada
Distribution US, Puerto Rico, & Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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