Reported Oct 11, 2023 · Ongoing
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Veran EndobronchialModels: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 00815686021313INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes 00815686021313 2 00815686021306INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes 00815686021306 3 00815686021290INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021290 4 00815686021276INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes 00815686021276 5 00815686021269INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021269 6 00815686021153INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes 00815686021153 7 00815686021108INS-5700 SPiN EWC Biopsy Guide Kit 00815686021108. All serial numbers and all lot numbers - Amount recalled
- 6484 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- DE
Why it was recalled
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
This product could cause temporary or reversible health problems — stop using it.
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