Olympus recalls B7-2Q balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units were sold in specific model series.
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 B7-2Q balloon catheters that may have poor sterile packaging seals. This could lead to infections if the catheters are used without proper sterility.
The catheters may have inadequate sterile packaging seals due to partial heat sealing. If the seal is compromised, the equipment might not be sterile, increasing infection risk during medical procedures.
Healthcare professionals using the B7-2Q balloon catheters for medical procedures are most at risk. Patients receiving these catheters could face infections if the equipment isn't properly sterilized.
Check for the model number B7-2Q on the catheter packaging. The product was sold in specific model series: 01K, 02K, 03K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK.
Inspect the packaging for signs of inadequate sealing, such as leaks or improper closure.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used.
The affected model numbers are B7-2Q, with specific series: 01K, 02K, 03K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK.
Check the packaging for the model number B7-2Q and the specific series listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0965-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0965-2021 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.
