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U.S. Department of Health and Human Services

Class 2 Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar

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  Class 2 Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar see related information
Date Initiated by Firm March 28, 2016
Date Posted April 22, 2016
Recall Status1 Terminated 3 on November 14, 2016
Recall Number Z-1559-2016
Recall Event ID 73783
Product Classification Culture media, selective and differential - Product Code JSI
Product Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar
Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016
Product is sold in cartons of 100 plates each.

Product Usage:
Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
Code Information Cat. Number Lot Number 221291 6034889 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact
410-316-4000
Manufacturer Reason
for Recall		 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD sent an Urgent Product Recall letter dated March 2016 to all US customers via UPS or email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected lots and discard any remaining product. BD will replace the discard inventory. Customers were asked to complete and fax the attached form to : Attention Regulatory Compliance, Fax: 410-316-4258 or email to BDRC2@bd.com.
Quantity in Commerce 88,300 plates (883 cartons)
Distribution US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
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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