ERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
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 medical device recall involving a risk of serious respiratory complications (aspiration pneumonia, acute respiratory distress syndrome, respiratory failure) that could require hospitalization, meeting the Severe threshold.
Plain-English summary
Erbe Medical, LLC is recalling ERBEFLO CleverCap CO2 hybrid CO2 tubing and cap sets designed for use with Olympus, Pentax, and Fujifilm endoscopes. The recalled devices were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from the distal tip under unsupported third-party connector use conditions.
Unintended water flow from the device may lead to water aspiration during endoscopic procedures. Water aspiration may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
The devices were distributed nationwide. Approximately 260,962 units have been recalled across multiple reference numbers and lot codes. Healthcare facilities using these devices should discontinue use and contact Erbe Medical for instructions on replacement or return of affected products.
The recalled product
- Product
- 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: 2
- Manufacturer
- Erbe Medical, LLC
- Hazard
- water-aspiration
- respiratory-distress
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 (20)
- 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
Distribution
Distributed nationwide across the United States.