Centurion Universal Line Full Body Drape Kit Recalled for Packaging Defect
Centurion Medical Products is recalling 80 units of Universal Line Full Body Drape Kits due to incomplete sterile packaging seals that may compromise product 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 (compromised sterility) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling 80 units of the Universal Line Full Body Drape Kit - REG (Code: DT11955). The recall involves Lot/Batch Number 2019052190 with an expiration date of 5/31/2024. The product was distributed nationwide.
The recall was initiated because sterile packaging seals may be incomplete, which could compromise the sterility of the product. This defect poses a risk of infection if the non-sterile product is used in a sterile field.
Healthcare facilities and consumers who have this specific product should stop using it and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Drapes
- Affected units
- 80
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)
- Lot/Batch Number: 2019052190 Exp Date: 5/31/2024
Distribution
Distributed nationwide across the United States.
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