Reported Feb 17, 2021 · Terminated
B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically…
Aomori Olympus Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aomori Olympus Co., Ltd. · 2 Chome 248-1 · Kuroishi, N/A · N/A
Is this the product you have?
- B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no
- B-V443Q-A - Product UsageUsed with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones
- Lot codes and dates
06V07V08V09V0XV
- Amount recalled
- 7,400,000 (global); 260,395 (US)
This recall covers 111 products
The agency filed one notice per product. You are reading one of them; the other 110 are below.
98 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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