medical Class I Updated 2024-12-25

Kirwan Surgical Products, LLC recalls Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model

Recalled Product

Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.

Hazard / Issue

Potential for the outer stainless-steel tube to break or detach.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/Catalog Number: 18241-0979. GTINs: Pouch - 00841019116623, Inner Pack - 10841019116620, Case - 20841019116627. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
View official government recall

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