Class 3 Device Recall Acumedia Nutrient Gelatin

• Date Initiated by Firm: March 23, 2016
• Date Posted: June 01, 2017
• Recall Status: Terminated on June 02, 2017
• Recall Number: Z-2213-2017
• Recall Event ID: 77275
• Product Classification: Culture media, non-selective and non-differential - Product Code JSG
• Product: Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microorganisms on the basis of gelatinase production. Identifying fermentative and non-fermentative Gram-negative bacilli include testing for gelatin liquefaction. If the proteolytic enzyme gelatinase is present, gelatin is hydrolyzed and loses its gelling characteristic.
• Code Information: PN 7471A, Lot 105550F
• FEI Number: 1120041
• Recalling Firm/ Manufacturer: Acumedia Manufacturers, Inc.; 740 E Shiawassee St; Lansing MI 48912-1218
• Manufacturer Reason for Recall: Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date of April 30, 2018.
• FDA Determined Cause: Error in labeling
• Action: On 3/23/2016, 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: 5 units
• Distribution: Worldwide - US Nationwide in the state of ME; in the country of ECUADOR
• 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.