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FDA DevicesClass I

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Veröffentlicht: 22. April 2026Rückruf-ID: Z-1798-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Recalling Firm: B Braun Medical Inc

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Produktbeschreibung & Identifikation

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Betroffene Produkte

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Additional Source Details

FieldValue
CityBethlehem
StatePA
Event id98552
Address 1824 12th Ave
Address 2N/A
Code infoModel Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025
Postal code18018-3524
Report date20260422
Product typeDevices
Product quantity3,158,104 units
Reason for recallPotential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260319
Initial firm notificationLetter
Center classification date20260415

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 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.?

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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Übersicht

  • Rückrufendes UnternehmenB Braun Medical Inc
  • StatusOngoing
  • RisikostufeClass I
  • DistributionWorldwide distribution - US Nationwide and the country of Canada.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

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🚨 SAFETY ALERT: B Braun Medical Inc - B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Check if your household is affected:
https://therecallfile.com/de/recalls/b-braun-hemodialysis-bloodlines-streamline-bloodline-set-for-dialog-dr/FDA-Z-1798-2026
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