Olympus recalls B5-2C balloon catheters with inadequate sterile packaging seals that could lead to infections. Affected units include specific model numbers and batch codes sold for medical use.
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.
Olympus is recalling B5-2C balloon catheters that may have poor sterile packaging seals. Using these catheters could lead to infections in patients during medical procedures.
The catheters may have inadequate sterile packaging seals, allowing non-sterile equipment to be used. This increases the risk of infections during medical procedures like bile duct injections.
Healthcare professionals using the B5-2C catheters for medical procedures are most at risk. Patients receiving procedures with these catheters could develop infections.
Check for model number B5-2C and batch codes 01K through 9ZK on the packaging. These catheters are used with endoscopes for medical procedures.
Inspect the packaging for signs of a partial heat seal that may compromise sterility.
Inspection confirmed a small percentage of sterile packages with inadequate package seals, which could lead to infections if non-sterile equipment is used.
Model B5-2C with batch codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK.
Look for model number B5-2C and batch codes 01K through 9ZK on the packaging. These catheters are used with endoscopes for medical procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0962-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0962-2021 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
