medical Class II Updated 2021-02-17

Aomori Olympus Co., Ltd. recalls CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used w

Recalled Product

CRESCENT SNARE, model no. SD-221U-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: 01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK
View official government recall

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