Class 2 Device Recall Acumedia Palcam Supplement

• Date Initiated by Firm: November 30, 2015
• Create Date: June 14, 2017
• Recall Status: Terminated on November 03, 2017
• Recall Number: Z-2584-2017
• Recall Event ID: 77283
• Product Classification: Culture media, selective and differential - Product Code JSI
• 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.
• Code Information: PN 7987, Lot 108044
• Recalling Firm/ Manufacturer: Acumedia Manufacturers, Inc.; 740 E Shiawassee St; Lansing MI 48912-1218
• For Additional Information Contact: John Guenther; 800-234-5333 Ext. 2362
• Manufacturer Reason for Recall: Contamination of product with possible Bacillus spp
• FDA Determined Cause: Process design
• Action: On 11/30/2015 and 1/21/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and offers replacement product.
• Quantity in Commerce: 28 units
• Distribution: Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.