Medical Device Recall: Z-0014-2008

FDA Recalls dataset · Firm: Pml Microbiologicals Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-04-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2008.

Recall Res Number
Z-0014-2008
Recalling Firm / Manufacturer
Pml Microbiologicals Inc.
FEI Number
3017344
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-04-23
Date Posted
2007-10-10
Date Terminated
2011-06-07
Product Code
JSO
Event Number
39382
Product Quantity
640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)
Product Description Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
Reason for Recall Plates manufactured without vancomycin. Possibility for false resistant results.
Action Details On 4/23/07 the firm began contacting customers via fax and telephone.
Distribution Pattern 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.
Code Information / Serial Numbers Lot numbers 229957-1 and 229958-1

Related Establishments / Registrations

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