Centurion Medical Products Recalls Dressing Trays Due to Incomplete Seals
Centurion Medical Products Corporation is recalling specific dressing trays and medical packs 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 injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of dressing trays, laceration trays, and medical packs. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the products.
The affected products include Dressing Trays, Major Dressing Trays, Minor Core Dressing Trays, Laceration Trays, Adult Lumbar Pumps, and Prep Packs. Specific lot codes are listed in the official recall notice. The products were distributed nationwide and to Ghana.
Consumers and healthcare facilities should stop using these products and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE…
- Manufacturer
- Centurion Medical Products Corporation
- 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.
See all 54 products in this recall →Related recalls
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