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U.S. Department of Health and Human Services

Class 2 Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202

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 Class 2 Device Recall Remel Blood Agar, 5 Sheep Blood REF R01202see related information
Date Initiated by FirmMay 04, 2015
Date PostedJune 10, 2015
Recall Status1 Terminated 3 on February 13, 2017
Recall NumberZ-1748-2015
Recall Event ID 71198
Product Classification Culture media, non-selective and non-differential - Product Code JSG
ProductRemel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Code Information Lot Number: 646595 and 646596 Expiration date: 19May2015
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactScott A. Kendall
770-409-0713
Manufacturer Reason
for Recall		Product may be contaminated with Listeria monocytogenes.
FDA Determined
Cause 2		Material/Component Contamination
ActionThe recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.
Quantity in Commerce845/10/10-plate pack cases
DistributionNationwide 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.
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