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U.S. Department of Health and Human Services

Class 2 Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood and MacConkey III Plate

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  Class 2 Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood and MacConkey III Plate see related information
Date Initiated by Firm March 11, 2013
Date Posted May 16, 2013
Recall Status1 Terminated 3 on June 24, 2013
Recall Number Z-1333-2013
Recall Event ID 64883
Product Classification Culture media, selective and differential - Product Code JSI
Product BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate.

Used for culturing microorganisms.
Code Information Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Ms. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall
Microbiological media may be contaminated with bacteria.
FDA Determined
Cause 2
Material/Component Contamination
Action BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.
Quantity in Commerce 521,160 total pieces (all three recalled products)
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico, Virgin Islands, and Guam and the countries of Columbia, Japan, Singapore, Canada, Turks, Calicos Islands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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