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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/
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		 Plates manufactured without vancomycin. Possibility for false resistant results.
FDA Determined
Cause 2		 Other
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.
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