Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp.

FDA device recall Z-1559-2016 · posted 2016-04-22 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JSI

Quantity affected

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.

Date initiated

2016-03-28

Date posted

2016-04-22

Date terminated

2016-11-14

Location

Sparks, MD