FDAFDA · Food and drugs·Recall number Z-0987-2021
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Published February 17, 2021 · Recall initiated: January 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aomori Olympus Co., Ltd.
- Distributor
- US Nationwide distribution.
- Lot
- 97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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