The Recall Desk
HighFDA (Devices)·Z-0344-2020·Announced 2019-11-13

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.

What this means for you

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
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.