Olympus Corporation of the Americas: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Olympus Corporation of the Americas
- Product
- Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- Reason / hazard
- Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
- Recall initiated
- 2026-08-19
- Code info
- Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots
- Product quantity
- 816 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 99609
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