FDAFDA · Food and drugs·Recall number Z-0978-2021
KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper 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
- 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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