Medical Device Recall: Z-0011-2008

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

Recall Action Class: N/A Date Initiated: 2007-08-17 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-2008.

Recall Res Number
Z-0011-2008
Recalling Firm / Manufacturer
Pml Microbiologicals Inc.
FEI Number
3017344
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-08-17
Date Posted
2007-10-10
Date Terminated
2011-06-07
Product Code
JSO
Event Number
39367
Product Quantity
1205 plates distributed in US; 1040 distributed in Canada
Product Description Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Reason for Recall Marketed a regulated product without a 510(k).
Action Details Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.
Distribution Pattern US, Puerto Rico, & Canada
Code Information / Serial Numbers PML's catalog #P1174, LOT CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1, 237378-1, 237917-1

Related Establishments / Registrations

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