Olympus recalls B7-2C balloon catheters with inadequate sterile packaging seals that could lead to infections if used improperly. Affected units include specific model numbers and batch codes.
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 certain B7-2C 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, meaning the equipment could become contaminated. If non-sterile equipment is used during medical procedures, patients may develop infections.
Medical professionals using the B7-2C balloon catheters for procedures involving bile ducts, pancreatic ducts, or respiratory organs. Patients receiving these procedures are at risk if non-sterile equipment is used.
Check for model number B7-2C and batch codes 01K through 9ZK. These catheters are used with endoscopes to inject contrast medium into bile ducts, pancreatic ducts, or respiratory organs.
Inspect the packaging for signs of inadequate sealing, such as leaks or improper closure.
The model number is B7-2C.
Batch codes 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK.
The recall states that the packaging may have inadequate seals, but no specific visual indicators are described in the official notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0963-2021 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.
