Erbe Medical recalls ERBEFLO 2 Endoscopy Pump Tubing/Cap Set (REF: 20325-222) due to potential water aspiration leading to pneumonia or respiratory failure. Affected units include specific lots.
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Set (REF: 20325-222) because improper use could cause water to flow into the patient's lungs, potentially leading to serious respiratory issues. This recall affects specific production lots.
The tubing's distal connector may allow water to flow into the patient's lungs if not properly secured during endoscopy. This can lead to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Healthcare professionals using endoscopes with this tubing set are most at risk. Patients undergoing procedures with the recalled tubing could experience water aspiration.
Check for the product name 'ERBEFLO 2 Endoscopy Pump Tubing/Cap Set' with reference number 20325-222. Affected units include specific production lots listed in the recall notice.
Look for lot numbers W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, or WO477014 on the tubing set.
Yes, improper use could lead to water aspiration, which may cause pneumonia, respiratory distress, or failure.
Check the lot number on the tubing set. If it matches the affected lots listed, contact Erbe Medical for instructions.
The product name is 'ERBEFLO 2 Endoscopy Pump Tubing/Cap Set' with reference number 20325-222. Affected units include specific production lots listed in the recall notice.
We’ve drafted a message you can send Erbe Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2064-2026 — Erbe Medical Erbe Medical Hello, I own a Erbe Medical that is covered by recall Z-2064-2026 from Erbe Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
