Device recall: Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Class I FDA enforcement event 93548. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Maquet Cardiovascular, LLC started this device recall on 13 Dec 2023. The firm address in the FDA record is in Wayne, NJ. FDA put the recall in Class I. FDA event 93548 has 2 product records. The first FDA enforcement report date is 24 Jan 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.
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Recalling firm
Maquet Cardiovascular, LLC, Wayne, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0709-2024 | Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection | (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS) | Class I | Ongoing | 24 Jan 2024 |
| Z-0710-2024 | Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit | (7,501 cases/45,006 devices US); no OUS | Class I | Ongoing | 24 Jan 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 I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 32
Other events of the firm
Official channels
- FDA enforcement report Z-0709-2024The 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 93548. https://recallregister.com/fda/i/93548/. 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) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
- What quantity of product is in FDA event 93548?
- The event has 2 product records. The first record gives this quantity:
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.