Device recall: MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Class II FDA enforcement event 93731. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 21 Dec 2023. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 93731 has 7 product records. The first FDA enforcement report date is 7 Feb 2024. The record gives the status Ongoing.
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 Nationwide distribution.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0963-2024 | MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A | 13860 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0964-2024 | MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A | 775 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0965-2024 | MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A | 4320 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0966-2024 | MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B | 500 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0967-2024 | MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 | 960 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0968-2024 | MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C | 4200 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0969-2024 | MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A | 2100 units | Class II | Ongoing | 7 Feb 2024 |
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 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-0963-2024The 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 93731. https://recallregister.com/fda/ii/93731/. 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 Nationwide distribution.
- What quantity of product is in FDA event 93731?
- The event has 7 product records. The first record gives this quantity:
13860 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.