Recall Z-2584-2017— Acumedia Manufacturers, Inc.

Class II · Terminated

Class II FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2015-11-30, terminated 2017-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.

Recalling firm
Acumedia Manufacturers, Inc.
Classification
Class II
Status
Terminated
Initiated
2015-11-30
Terminated
2017-11-03
Firm location
Lansing, MI, United States

Product 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 for recall

Contamination of product with possible Bacillus spp

Data sourced from openFDA. This site is unofficial and independent of the FDA.