Centurion Recalls Umbilical Trays Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling specific umbilical trays because incomplete seals on the sterile package 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 involves a risk-of-harm product (sterile medical device) where the hazard (compromised sterility) is theoretical and no injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of umbilical trays, including umbilical artery trays, umbilical vessel catheter trays, and umbilical catheter insertion trays. The recall is being conducted because incomplete seals on the sterile package may compromise the sterility of the devices.
The affected products were distributed nationwide and to Ghana. The recall includes specific lot numbers for various tray models, such as UVT1045, UVT1055, UVT1065, UVT170, UVT280, UVT460, UVT505, UVT630, UVT640, UVT665, UVT730, UVT795, UVT960A, and UVT970.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for return are provided in the source text, so facilities should contact Centurion Medical Products Corporation for further guidance.
The recalled product
- Product
- Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630…
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
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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