K-202 GUIDE SHEATH Kit 2 recalled over sterility concerns
- Recall date
- January 4, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aomori Olympus Co., Ltd. recalls K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimen…
- Recall number
- Z-0971-2021
- FDA classification
- Class II
- Brand / firm
- Aomori Olympus Co., Ltd.
- Sold / distributed
- US Nationwide distribution.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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