Erbe Medical, LLC: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Erbe Medical, LLC
- Product
- ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.
- Recall initiated
- 2026-03-31
- Code info
- UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014
- Product quantity
- 5,500
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tempe
- State
- AZ
- Country
- United States
- Event id
- 98674
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