CLASS I ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

Product REF 4000-100N, Drain, Express Single W/AC, Single Collection recalled

Maquet Cardiovascular is recalling Product REF 4000-100N, Drain, Express Single W/AC, Single Collection, distributed nationwide in the US. The recall was initiated on 13 Dec 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI-DI 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080

Quantity recalled(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0709-2024
FDA event ID: 93548
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class I
Status: Ongoing
Recall initiated: 13 Dec 2023
FDA classified: 12 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Dec 2023	Recall initiated by company
12 Jan 2024	Classified by FDA	+30 days
24 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

Where it was distributed

Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080

Where was it sold?

Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 93548

This product is part of a recall event; the main page for the event is Product REF 4050-100N, Drain, Express BRU W/AC, Blood Recovery Unit recalled.

Reported	Class	Recall	Company	Reason	Where
24 Jan 2024	CLASS I	Product REF 4050-100N, Drain, Express BRU W/AC, Blood Recovery Unit recalled	Maquet Cardiovascular	Sterility	Nationwide

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