Medical device recalls Moderate risk

Acumedia Manufacturers product recalled over Listeria risk

Recall date
November 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Acumedia Manufacturers, Inc. recalls Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a suppl…
Recall number
Z-2584-2017
FDA classification
Class II
Brand / firm
Acumedia Manufacturers, Inc.
Sold / distributed
Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,

Why it was recalled

Contamination of product with possible Bacillus spp

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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