Class 2 Device Recall BHIA

• Date Initiated by Firm: April 23, 2007
• Date Posted: October 10, 2007
• Recall Status: Terminated 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: 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.