FDA Enforcement Class II Terminated

Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.

Recall: Z-2584-2017 · Reported June 21, 2017

Enforcement

Recall Number
Z-2584-2017
Event ID
77283
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Acumedia Manufacturers, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
June 21, 2017
Initiation Date
November 30, 2015
Classification Date
June 14, 2017
Termination Date
November 3, 2017
Address
740 E Shiawassee St, N/A, Lansing, MI, 48912-1218, United States

Description

Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.

Reason

Contamination of product with possible Bacillus spp

Code Info

PN 7987, Lot 108044

Distribution

Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,

Quantity

28 units