Endoscopy Pump Tubing/Cap Set water aspiration risk recall
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a potential pathway to serious patient harm. The source describes a risk that may lead to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure, which constitute serious conditions that could require hospitalization, satisfying the rubric criterion for Severe (Class II with serious injury risk).
Plain-English summary
Erbe Medical, LLC is recalling the ERBEFLO 2 Endoscopy Pump Tubing/Cap Set (REF: 20325-222) nationwide. Approximately 5,500 units were distributed across all 50 states and Puerto Rico.
The recalled devices provide sterile water, CO2, or air to endoscopes. They were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from the distal tip when used with unsupported third-party connectors. This condition could allow water aspiration during endoscopy procedures.
Water aspiration may progress to serious respiratory complications, including aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure. The affected lot numbers are W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, and WO477014 (UDI-DI: 04065655000252).
Facilities using these devices should verify whether they have affected inventory and consider discontinuing use or modifying procedures to avoid third-party connector use with these devices. Contact Erbe Medical, LLC with questions or to report any adverse events.
The recalled product
- Product
- ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
- Manufacturer
- Erbe Medical, LLC
- Hazard
- water-aspiration
- respiratory-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- UDI-DI: 04065655000252. Lots: W4465580
- W4466022
- W4466023
- WO469442
- WO469923
- WO473978
- WO473979
- WO473980
- WO473981
- WO476347
- WO477013
- WO477014
Distribution
Distributed nationwide across the United States.