medical Class II Updated 2021-02-17

Aomori Olympus Co., Ltd. recalls SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage

Recalled Product

SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V
View official government recall

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