Z-0528-2019Class II

BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)

Name: Z-0528-2019 BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Creator: Becton Dickinson & Co.
Published: 2018-10-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-10-22 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential) on 2018-10-22. FDA classified it as Class II and gives the reason as "a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms". 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-0528-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2018-11-30
Terminated: 2020-04-03
Recalling firm: Becton Dickinson & Co
Product: BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
Product code: JSG Culture Media, Non-Selective And Non-Differential
Reason for recall: a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Distributors were notified via email on October 22, 2018, requesting their customer distribution list. Customer letters were sent via UPS beginning on October 29, 2018. **Distributors are Advised to do the following: 1.Discard any remaining inventory of the above referenced product. 2.Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 3.Within three days, provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from your distribution branches so we may inform them of this issue. Fax or email to: BD Regulatory Compliance Fax: 410-316-4258 Email: [email protected] 4.A copy of the customer communication is attached for your records. **Customers area Advised to Take the Following Action(s): 1. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Discard any remaining inventory of lot 8221508. BD will process replacement of any discarded inventory upon receipt of the Customer Response Form. 3. Share a copy of the Recall Letter with all users of the product within your facility to ensure awareness. Customers with questions may call 800-638-8663, Monday through Friday 7 am - 7 pm, EST.
Quantity in commerce: 54,300 plates
Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV
Product codes and lots: UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0528-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code JSG

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)