Exact FDA event identifier

Event 73390

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

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
Recalling firm: Maquet Cardiovascular Us Sales, Llc
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
Recalling firm: Maquet Cardiovascular Us Sales, Llc
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
Recalling firm: Maquet Cardiovascular Us Sales, Llc
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
Recalling firm: Maquet Cardiovascular Us Sales, Llc
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.