CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator recalled

Maquet Cardiovascular Us Sales is recalling Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator, distributed nationwide in the US. The recall was initiated on 23 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.

Quantity recalled72,000 units in total

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-1373-2016
FDA event ID: 73390
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 23 Feb 2016
FDA classified: 12 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Feb 2016	Recall initiated by company
12 Apr 2016	Classified by FDA	+49 days
20 Apr 2016	Published in enforcement report	+8 days

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

Reason for recall

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Product as listed by the FDA

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Which lots are affected?

BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.

Where was it sold?

US Nationwide Distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

3 other products · FDA event 73390

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016	CLASS II	Quadrox-i oxygenators Custom tubing packs for the oxygenator recalled	Maquet Cardiovascular Us Sales	Other	Nationwide
20 Apr 2016	CLASS II	HLS Set Advanced with Bioline Coating Custom tubing packs recalled	Maquet Cardiovascular Us Sales	Other	Nationwide
20 Apr 2016	CLASS II	Custom Tubing Packs Custom tubing pack for oxygenators recalled	Maquet Cardiovascular Us Sales	Other	Nationwide

More recalls from Maquet Cardiovascular Us Sales

All 62

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
18 Nov 2020Device	CLASS II	Blood Monitoring Unit (BMU recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Temperature Abuse	Nationwide
28 Oct 2020Device	CLASS II	Yuno II Mobile Operating Table recalled	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide
28 Oct 2020Device	CLASS II	Yuno Mobile Operating Table recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide

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