FDAClass IDecember 25, 2024

Accutome/Microsurgical Disposable Bipolar Pencil 5 in recall

Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar…

Why was Accutome/Microsurgical Disposable Bipolar Pencil 5 in 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: AB-7004. GTINs: Pouch - 00841019113875, Inner Pack - 10841019113872, Case - 20841019113879. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.

Product
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar…
Recalling firm
Kirwan Surgical Products, LLC
Quantity
800 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)
Open FDA enforcement record Latest recalls