Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Summary
The FDA issued a Class III for Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. by Aizu Olympus Co., Ltd.. Reason: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remain.
Details
Source
Device Recall
External ID
Z-0330-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Lot/Code Info: Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).
Quantity Affected: 3 units
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
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-25
Company
Aizuwakamatsu, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aizu Olympus Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aizu Olympus Co., Ltd. have FDA actions?
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0330-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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