Centurion Medical Products Recalls Sterile Dressing Change Trays Due to Seal Defects
Centurion Medical Products Corporation is recalling various sterile dressing change trays and procedure 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. The hazard involves a risk of infection due to compromised sterility, which is a significant health risk, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling multiple lots of sterile dressing change trays, central line preparation packs, and procedure kits. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products include a wide range of trays and kits used for central line, PICC, port, and vascular access procedures. The specific lot numbers are listed in the official recall notice. The products were distributed nationwide and to Ghana.
Healthcare facilities and consumers should stop using the affected products and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT…
- Manufacturer
- Centurion Medical Products Corporation
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
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