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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86577

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 30, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet Cardiovascular Us Sales, Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

Z-0443-2021
Recall number
Z-0443-2021
Initiated
September 30, 2020
Classification
Class II
Status
Terminated
Quantity
51 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

Code information

Serial numbers 90002022 90002134 90002163 90002187 90002276 90002297 90002023 90002135 90002164 90002188 90002277 90002298 90002024 90002136 90002168 90002191 90002279 90002302 90002029 90002137 90002170 90002194 90002280 90002306 90002047 90002140 90002172 90002195 90002281 90002312 90002112 90002143 90002181 90002196 90002287 90002313 90002123 90002144 90002183 90002210 90002289 90002124 90002160 90002184 90002212 90002293 90002133 90002161 90002185 90002273 90002296

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia, Malta, Netherlands, Norway, Pakistan, Peru, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.