FDA DevicesClass II

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Publicado: 11 de febrero de 2026ID de Retiro: Z-1300-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Recalling Firm: Maquet Cardiopulmonary Gmbh

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Motivo del Retiro / Peligro

Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

Descripción del Producto e Identificación

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Productos Afectados

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Additional Source Details

FieldValue
CityRastatt
StateN/A
Event id98159
Address 1Kehler Str. 31
Address 2N/A
Code infoModel Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;
Postal codeN/A
Report date20260211
Product typeDevices
Product quantity3050 units
Reason for recallInternal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260109
Initial firm notificationLetter
Center classification date20260205

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableMaquet Cardiopulmonary Gmbh
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionWorldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Maquet Cardiopulmonary Gmbh - Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

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https://therecallfile.com/es/recalls/bubble-sensor-for-3-8-x-3-32-tubing-model-number-701055720/FDA-Z-1300-2026
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