Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73390

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 23, 2016
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

4 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 4

QUADROX-i oxygenators Custom tubing packs for the oxygenator

Z-1371-2016
Recall number
Z-1371-2016
Initiated
February 23, 2016
Classification
Class II
Status
Terminated
Quantity
72,000 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx, BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U, X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100

Distribution pattern

US Nationwide Distribution.

device · product 2 of 4

HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

Z-1372-2016
Recall number
Z-1372-2016
Initiated
February 23, 2016
Classification
Class II
Status
Terminated
Quantity
72,000 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786

Distribution pattern

US Nationwide Distribution.

device · product 3 of 4

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

Z-1373-2016
Recall number
Z-1373-2016
Initiated
February 23, 2016
Classification
Class II
Status
Terminated
Quantity
72,000 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US Nationwide Distribution.

device · product 4 of 4

Custom Tubing Packs Custom tubing pack for oxygenators

Z-1374-2016
Recall number
Z-1374-2016
Initiated
February 23, 2016
Classification
Class II
Status
Terminated
Quantity
72,000 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx, and BEQ-TOP xxxxx.

Distribution pattern

US Nationwide Distribution.