Z-0329-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3344 units
Product Description
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.
Reason for Recall
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
Model Number (UDI-DI): CF-2T160I (04953170307645), CF-2T160L (04953170307652), CF-H170I (04953170334184), CF-H170L (04953170334160), CF-H180AI (04953170339585), CF-H180AL (04953170339608), CF-H180DI (04953170339639), CF-H180DL (04953170339653), CF-H190I (04953170305177), CF-H190L (04953170305153), CF-HQ190I (04953170305139), CF-HQ190L (04953170305115), CF-LV1I (04953170312410), CF-LV1L (04953170312397), CF-Q150I (04953170307621), CF-Q150L (04953170307638), CF-Q160S (04953170307669), CF-Q180AI (04953170307690), CF-Q180AL (04953170307706).