—#168983

Product

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

FDA product code: JSG — Culture Media, Non-Selective And Non-Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2018-10-22
Posted by FDA: 2018-11-30
Terminated: 2020-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.