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.
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: 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.
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