Device recall: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is…
Class II FDA enforcement event 69091. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Becton Dickinson & Co. started this device recall on 6 Jun 2014. The firm address in the FDA record is in Sparks, MD. FDA put the recall in Class II. FDA event 69091 has 3 product records. The first FDA enforcement report date is 21 Jan 2015. The record gives the status Terminated, with the termination date 12 Aug 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Recalling firm
Becton Dickinson & Co., Sparks, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0974-2015 | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and… | 7,617 cases (100 plates/case) | Class II | Terminated | 21 Jan 2015 |
| Z-0975-2015 | CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic… | 1,530 cases (100 plates/case) | Class II | Terminated | 21 Jan 2015 |
| Z-0976-2015 | Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species. | 775 cases | Class II | Terminated | 21 Jan 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 77
Other events of the firm
Official channels
- FDA enforcement report Z-0974-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 69091. https://recallregister.com/fda/ii/69091/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
- What quantity of product is in FDA event 69091?
- The event has 3 product records. The first record gives this quantity:
7,617 cases (100 plates/case)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.