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U.S. Department of Health and Human Services

Class 3 Device Recall Acumedia Beef Extract Powder

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 Class 3 Device Recall Acumedia Beef Extract Powdersee related information
Date Initiated by FirmSeptember 11, 2015
Date PostedJune 01, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall NumberZ-2214-2017
Recall Event ID 77272
Product Classification Supplement, culture media - Product Code JSK
ProductBeef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
Code Information PN 7228, Lot 107984A
Recalling Firm/
Manufacturer		 Acumedia Manufacturers, Inc.
740 E Shiawassee St
Lansing MI 48912-1218
For Additional Information ContactJohn Guenther
800-234-5333 Ext. 2362
Manufacturer Reason
for Recall		Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019.
FDA Determined
Cause 2		Error in labeling
ActionOn 9/11/2015, 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 information for the correction to product.
Quantity in Commerce16 units
DistributionWorldwide - US Nationwide in the state IL and the country of COLOMBIA
Total Product Life CycleTPLC 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.
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