FDA-Device2023-09-13Class II
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Aomori Olympus Co., Ltd.
Hazard
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Sold states
US Nationwide distribution.
Affected count
1,048 units
Manufactured in
2 Chome 248-1, Okkonoki, Kuroishi, N/A, Japan
Products
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2522-2023Don't want to check this manually?
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