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Aomori Olympus Co., Ltd. Recall: SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 -

Aomori Olympus Co., Ltd. Recall: SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Aomori Olympus Co., Ltd.; Product: SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically

Recalling firmAomori Olympus Co., Ltd.
ProductSD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Reason for recallInspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Nationwide distribution.
Recall initiated20210104
Recall numberZ-0987-2021
Categorydevice
StateN/A
CountryJapan

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