FDAClass IDecember 25, 2024

Walcott Bipolar Pencil 25 Gauge Straight recall

Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are…

Why was Walcott Bipolar Pencil 25 Gauge Straight recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog Number: RX14-5011. GTINs: Pouch - 00841019109922, Inner Pack - 10841019109929, Case - 20841019109926. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

Product
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are…
Recalling firm
Kirwan Surgical Products, LLC
Quantity
3,010 units
Distribution
Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.
Recall date
December 25, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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