Z-0196-2018Class II

TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or...

Name: Z-0196-2018 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or...
Creator: Becton Dickinson & Co.
Published: 2017-05-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-05-22 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious... on 2017-05-22. FDA classified it as Class II and gives the reason as "Listeria monocytogenes contamination of non-sterile plated media". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0196-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-12-06
Terminated: 2018-02-26
Recalling firm: Becton Dickinson & Co
Product: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Listeria monocytogenes contamination of non-sterile plated media
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD Life Sciences initiated communication with distributors by issuing Urgent Product Recall and Customer Response Form notices via UPS mailing on May 22, 2017. General customers were issued Urgent Product Recall and Customer Response Form letters via UPS mailing on May 25, 2017. - General customers were advised to visually inspect all non-sterile prepared media prior to use to assure that there is no surface and/or subsurface contamination. If the customer observes a plate without evidence of microbial contamination that grows Listeria, please consult the clinician to make sure this result is consistent with the patient's clinical presentation. - Distributors were advised to discontinue distribution of the lots and to discard any remaining inventory. Customers are advised to complete and return the enclosed response form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or email to [email protected] **Note to Distributors: Please provide BD Regulatory Compliance an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so they can be notified. Mail or fax to: BD Regulatory Compliance 7 Loveton Circle Mail Stop 640, Sparks, MD 21152 Fax: 410-316-4258; Email: [email protected]. Customers with questions please contact BD Support at 1-800-638-8663. For customers outside of the U.S., contact your local BD representative or distributor. For questions regarding this recall call 410-316-4000.
Quantity in commerce: 250, 300 plates
Distribution: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan
Product codes and lots: Lot Number: 7032978 - Exp Date May 24, 2017 7048902 - Exp Date June 9, 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0196-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0196-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

Product code JSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)