Device product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 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.
Z-0654-2025
Product summary
- Event
- Event 95753
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 80,060 units
- Official record key
device-enforcement:Z-0654-2025
Official wording
Reason: Potential for the outer stainless-steel tube to break or detach.
Code information: Model/Catalog Number: 14-5011. GTINs: Pouch - 00841019101049, Inner Pack - 10841019101046, Case - 20841019101043. Sterile Lot Range: 220906 to 241002. All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for the outer stainless-steel tube to break or detach.