Agency classClass IIOur severity:High FDA (Devices)·Z-2083-2015·Announced 2015-07-22

Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure

Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a functional defect (loss of suction capability) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 104 units of the FLOW-i Anesthesia System Auxiliary O2 and Suction Module, Device Part number 66 79 847. The recall was initiated because the suctioning function in some modules cannot be activated or controlled by the suction unit on/off switch, leading to a decrease or loss of suctioning capability.

The affected modules were distributed worldwide, including nationwide in the United States and internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and the United Arab Emirates. The FLOW-i Anesthesia System is indicated for administering inhalation anesthesia and controlling ventilation for patients with no ability to breathe or limited ability to breathe, from neonatal to adult patients, in hospital environments.

Healthcare professionals should contact Maquet for instructions on how to address the defect. The specific serial numbers affected are listed in the recall documentation.

The recalled product

Product: The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting…
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Anesthesia Equipment
Hazard: functional-defect
loss-of-suction
Affected units: 104

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Device Part number: 66 79 847 Serial Numbers: 4
14-24
26-29
31
37
40
56
138
199
205
367
369-372
391
394-395
416
466-491
517
519
525
567-568

Distribution

Distributed nationwide across the United States.

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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