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U.S. Department of Health and Human Services

Class 1 Device Recall Disposable Bipolar Pencil

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 Class 1 Device Recall Disposable Bipolar Pencilsee related information
Date Initiated by FirmNovember 14, 2024
Date PostedDecember 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0659-2025
Recall Event ID 95753
510(K)NumberK864402 
Product Classification Electrosurgical cutting and coagulation; and accessories - Product Code GEI
ProductNidek 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.
Code Information 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.
FEI Number 1219619
Recalling Firm/
Manufacturer		 Kirwan Surgical Products, LLC
180 Enterprise Dr
Marshfield MA 02050-2110
For Additional Information ContactMatthew R. Prario
US-781-8349500
Manufacturer Reason
for Recall		Potential for the outer stainless-steel tube to break or detach.
FDA Determined
Cause 2		Device Design
ActionKirwan Surgical Products notified customers on 11/14/2024 via URGENT MEDICAL DEVICE RECALL letter. Customers were instructed to return any affected units, notify all customer if affected product was further distributed and request they return them, and complete and return the Response Form provided in the notification.
Quantity in Commerce925 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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