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U.S. Department of Health and Human Services

Class 2 Device Recall Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin

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 Class 2 Device Recall Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycinsee related information
Date Initiated by FirmApril 22, 2021
Create DateMay 12, 2021
Recall Status1 Terminated 3 on August 08, 2023
Recall NumberZ-1561-2021
Recall Event ID 87830
510(K)NumberK972359 
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
ProductRemel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Code Information Lot #248035, Exp. 2021-04-27
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactTechnical Services
913-895-4077
Manufacturer Reason
for Recall		The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionThe recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts.
Quantity in Commerce91/10-test units
DistributionUS Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.
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.
510(K) Database510(K)s with Product Code = JSO
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