Centurion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
Centurion Medical Products Corporation is recalling HT5555A Hyperalimentation & Dressing Change Trays due to incomplete seals that 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 medical device where a defect (incomplete seals) may compromise sterility, posing a risk of harm without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling the HT5555A Hyperalimentation & Dressing Change Tray. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the product.
The affected product is the HT5555A Hyperalimentation & Dressing Change Tray, manufactured by Centurion Medical Products Corporation. The specific lot code associated with this recall is HT5555A HYPERALIMENTATION & DRSG CHG TRAY 2019021190. The product was distributed nationwide and in Ghana.
Consumers and healthcare facilities should stop using the affected trays and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Sterile Trays
- Hazard
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)
- Product-Lot Code: HT5555A HYPERALIMENTATION & DRSG CHG TRAY 2019021190
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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