Device recall: BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The…
Class III FDA enforcement event 80388. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Becton, Dickinson and Company, BD Biosciences started this device recall on 16 May 2018. The firm address in the FDA record is in San Jose, CA. FDA put the recall in Class III. FDA event 80388 has 1 product record. The first FDA enforcement report date is 8 Aug 2018. The record gives the status Terminated, with the termination date 13 Aug 2018.
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.
US Distribution was made to FL, KS, KY, MA, NJ, and SD.
Recalling firm
Becton, Dickinson and Company, BD Biosciences, San Jose, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2598-2018 | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and… | 8 devices | Class III | Terminated | 8 Aug 2018 |
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 III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class III
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 22
Other events of the firm
Becton, Dickinson and Company, BD Biosciences: all 22 events
Official channels
- FDA enforcement report Z-2598-2018The 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 80388. https://recallregister.com/fda/iii/80388/. 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:
US Distribution was made to FL, KS, KY, MA, NJ, and SD.
- What quantity of product is in FDA event 80388?
- The FDA record gives this quantity:
8 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 4% of the 1,074 device events that started in 2018 are in Class III.