Olympus Distal Attachment and Disposable EMR Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
---|---|---|
Distal Attachment |
All lots. |
MAJ-296 |
Disposable Emr Kit |
More than 10 numbers, contact manufacturer. |
K-011 |
Issue
Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP.
Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using the subject products and to further remove them.
In general, potential patient harms associated with the use of plastic products containing DEHP include:
chemical exposure, hypersensitivity/allergic reaction, endocrine disruption, reproductive and
developmental toxicity and carcinogenicity. Long term DEHP toxicity may occur if a distal attachment
inadvertently becomes a retained foreign body with resultant leaching over time. Olympus has not
received any reports of these harms occurring from the use of our products.
Recall start date: August 17, 2023
Additional information
Details
Olympus Medical Systems Corp. |
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507 |
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