Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential breach of sterility if seals fail, representing a risk of serious infection. As the source text does not report any actual patient harm, the score follows guidance that theoretical hazards without reported illness score at most 3.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling six types of Centurion Manual surgical kits: Hegar Uterine Dilators in multiple sizes (1-2mm, 5-6mm, 9-10mm, and 11-12mm) and Hank Uterine Dilators (11 inch 7/8FR and 11 inch 13/14FR models), all sterile. A total of 270 units have been recalled.
The products may have weak seals on their sterile packaging. If the seal fails, the contents may become non-sterile or contaminated. The weak seal is not easily detectable by users, creating a risk that compromised products may be used.
The affected products were distributed worldwide including the United States, Panama, and Canada. Specific lot numbers are associated with each product code.
The recalled product
- Product
- 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, STERI
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- compromised-sterility
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
Distribution
Distributed nationwide across the United States.
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