• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Acumedia Palcam Supplement

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Acumedia Palcam Supplement see related information
Date Initiated by Firm November 30, 2015
Create Date June 14, 2017
Recall Status1 Terminated 3 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/
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 2
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.