Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects
Centurion Medical Products is recalling various sterile dressing change kits and trays 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 involves a risk-of-harm product (sterile medical device) where the defect (compromised sterility) poses a risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling multiple lots of sterile dressing change kits, central line trays, and port access kits. The recall is due to incomplete seals on the sterile packaging, which may compromise the sterility of the medical devices.
The affected products include various models such as PICC insertion trays, central line trays, CVC dressing change trays, and port access kits. The recall covers lots distributed nationwide and in Ghana.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800…
- Manufacturer
- Centurion Medical Products Corporation
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 (2)
- CENTRAL LINE 2019031490 DYNDC1796C TRAY
- CENTRAL LINE 2019012890 DYNDC1800 TRAY
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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