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U.S. Department of Health and Human Services

Class 2 Device Recall BHIA

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  Class 2 Device Recall BHIA see related information
Date Initiated by Firm April 23, 2007
Date Posted October 10, 2007
Recall Status1 Terminated 3 on June 07, 2011
Recall Number Z-0014-2008
Recall Event ID 39382
Product Classification Microbiological media plates - Product Code JSO
Product Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA

Catalog #P1174
Code Information Lot numbers 229957-1 and 229958-1 
Recalling Firm/
Pml Microbiologicals Inc.
27120 Sw 95th Ave
P.o. Box 570
Wilsonville OR 97070
For Additional Information Contact
Manufacturer Reason
for Recall
Plates manufactured without vancomycin. Possibility for false resistant results.
FDA Determined
Cause 2
Action On 4/23/07 the firm began contacting customers via fax and telephone.
Quantity in Commerce 640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)
Distribution lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center. lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribution center.
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.