Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0330-2024 — Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

U.S. FDA — Device Enforcement · Japan · 2023-09-25 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0330-2024
Date of alert
2023-09-25
Country / jurisdiction
Japan
Risk level
Class III
Risk type
recall
Brand
Aizu Olympus Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170068751
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.