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Class 3 Device Recall Acumedia Beef Extract Powder |
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Date Initiated by Firm |
September 11, 2015 |
Date Posted |
June 01, 2017 |
Recall Status1 |
Terminated 3 on June 02, 2017 |
Recall Number |
Z-2214-2017 |
Recall Event ID |
77272 |
Product Classification |
Supplement, culture media - Product Code JSK
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Product |
Beef 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.
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Code Information |
PN 7228, Lot 107984A |
Recalling Firm/ Manufacturer |
Acumedia Manufacturers, Inc. 740 E Shiawassee St Lansing MI 48912-1218
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For Additional Information Contact |
John Guenther 800-234-5333 Ext. 2362
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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.
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FDA Determined Cause 2 |
Error in labeling |
Action |
On 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 Commerce |
16 units |
Distribution |
Worldwide - US Nationwide in the state IL and the country of COLOMBIA |
Total Product Life Cycle |
TPLC Device Report
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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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