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U.S. Department of Health and Human Services

Class 3 Device Recall Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20

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  Class 3 Device Recall Acumedia Sabouraud Dextrose Agar w /Lecithin and Tween 20 see related information
Date Initiated by Firm August 08, 2016
Date Posted June 01, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2212-2017
Recall Event ID 77281
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product Sabouraud Dextrose Agar w /Lecithin and Tween 20
Acumedia PN 91081

Product Usage:
Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Code Information PN 91081C, Lot 108367A PN 91081C, Lot 107632A
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		 Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
FDA Determined
Cause 2		 Error in labeling
Action On 8/8/2016 and 10/6/2016, 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 information for the correction to product.
Quantity in Commerce 10 units
Distribution US in the state of IL
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.
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