Reported Apr 10, 2024 · Ongoing
Centurion Manual surgical kits labeled as
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Centurion Manual surgical kits labeled as
6 of 6 products
| Model / number | Product as published |
|---|---|
HUD112ST | HEGAR UTERINE DILATOR, 11-12MM, STERILE |
HUD12ST | STERILE UTERINE DILATOR 1MM/2MM |
HUD56ST | HEGAR UTERINE DILATOR, 5-6MM, STERILE |
HUD910ST | HEGAR UTERINE DILATOR, 9-10MM, STERILE |
I68920 | HANK UTERINE DILATOR 11" 7/8FR STERILE |
I68930 | HANK UTERINE DILATOR 11" 13/14FR STERILE |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 5065316006828800653160068283HUD112ST, UDI/DI 50653160068288 (case) 00653160068283 (each), Lot Numbers: 2023032190 2 0065316028881010653160288817HUD12ST, UDI/DI 00653160288810 (case) 10653160288817 (each), Lot Numbers: 2023061690, 2023112990 3 5065316006825700653160068252HUD56ST, UDI/DI 50653160068257 (case) 00653160068252 (each), Lot Numbers: 2023112190 4 5065316006827100653160068276HUD910ST, UDI/DI 50653160068271 (case) 00653160068276 (each), Lot Numbers: 2023031390 5 0065316035132310653160351320I68920, UDI/DI 00653160351323 (case) 10653160351320 (each), Lot Numbers: 2023110290 6 0065316035129310653160351290I68930, UDI/DI 00653160351293 (case) 10653160351290 (each), Lot Numbers: 2023110990 - Amount recalled
- 270 units
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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