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

Recall number

Z-0528-2019

Recalling firm

Becton Dickinson & Co.

Product

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

Status

Terminated

Initiated

2018-10-22

Posted

2018-11-30

Terminated

2020-04-03

Reason

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

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: BDRC2@bd.com 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

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

Lot, serial or model codes

UDI - (01)10382902212611(17)181130  (10)8221508  Lot No.: 8221508  Expiration Date: 2018-11-30

510(k) numbers

not on file

PMA numbers

not on file

Product code

JSG

Firm FEI

1119779

Firm city

Sparks

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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