Centurion Medical Recalls Sterile NICU Line Change Kits Due to Seal Issues
Centurion Medical Products Corporation is recalling 160 sterile NICU line change kits because incomplete seals may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II and involves a risk of harm (compromised sterility) without reported illness or injury, meeting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling 160 units of the Centurion LC145 Sterile NICU Line Change Kit. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the product.
The affected product is identified by Lot Code 2018111590. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide and in Ghana.
Consumers and healthcare facilities should stop using the affected kits and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- Centurion- LC145 STERILE NICU LINE CHANGE KIT
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Sterile Kits
- Hazard
- Affected units
- 160
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 (1)
- Lot Code: 2018111590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 54 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCenturion Universal Line Full Body Drape Kit Recalled for Packaging Defect
FDA (Devices) · 2019-11-13
- HighCenturion Clamp kits recalled due to potential sterility breach risk
FDA (Devices) · 2024-04-10
- HighCenturion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk
FDA (Devices) · 2024-04-10
- HighCenturion Surgical Hook Kits Recalled Due to Weak Seal
FDA (Devices) · 2024-04-10
- HighCenturion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk
FDA (Devices) · 2024-04-10
- HighCenturion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14