FDAFDA · Food and drugs·Recall number Z-1450-2024
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930
Published April 10, 2024 · Recall initiated: February 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Lot
- a) HUD112ST, UDI/DI 50653160068288 (case) 00653160068283 (each), Lot Numbers: 2023032190; b) HUD12ST, UDI/DI 00653160288810 (case) 10653160288817 (each), Lot Numbers: 2023061690, 2023112990; c) HUD56ST, UDI/DI 50653160068257 (case) 00653160068252 (each), Lot Numbers: 2023112190; d) HUD910ST, UDI/DI 50653160068271 (case) 00653160068276 (each), Lot Numbers: 2023031390; e) I68920, UDI/DI 00653160351323 (case) 10653160351320 (each), Lot Numbers: 2023110290; f) I68930, UDI/DI 00653160351293 (case) 10653160351290 (each), Lot Numbers: 2023110990
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.