ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Source...
Reason for Recall / 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.
Product Description & Identification
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98674 |
| Address 1 | 405 W Geneva Dr |
| Code info | REF/UDI-DI/Lots: 20325-239/04065655000375/W4464506, W4464507, W4464512, W4464514, W4464515, W4464516, W4464517, W4465114, W4465115, W4465116, W4465702, W4465709, W4465991, W4466004, W4466266, W4466267, W4466268, W4466269, W4466271, W4466272, W4466273, W4466275, W4466278, W4466279, W4466813, W4466814, W4466815, W4466816, W4467057, W4467058, W4467059, W4467680, W4467681, W4468147, W4468148, W4468273, W4468274, W4468275, WO468776, WO468777, WO468778, WO468779, WO468780, WO469443, WO469444, WO469448, WO469449, WO469450, WO469451, WO469452, WO469933, WO469934, WO469947, WO469948, WO469949, WO469950, WO469951, WO469952, WO470768, WO470774, WO470775, WO470776, WO470777, WO470778, WO470896, WO470897, WO470913, WO470914, WO470915, WO470922, WO471236, WO471237, WO471238, WO471239, WO471240, WO471241, WO471242, WO473987, WO473988, WO473989, WO473991, WO475246, WO475247, WO475248, WO475249; 20325-240/04065655000405/W4466020, W4466021, WO468768, WO468769, WO468770, WO468771, WO469445, WO469446, W... [TRUNCATED] |
| Postal code | 85282-2003 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 260,962 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260331 |
| Center classification date | 20260501 |
Overview
- Recalling FirmErbe Medical, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.