The Recall Desk
HighFDA (Devices)·Z-1077-2020·Announced 2020-02-12

Centurion Medical Valve Change Kit Recalled for Incomplete Sterile Seals

Centurion Medical Products Corporation is recalling Valve Change Kits due to incomplete sterile package seals that may compromise 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 medical device where compromised sterility poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Centurion Medical Products Corporation is recalling the Centurion-Trays EBSI1021 Valve Change Kit- Double. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the product.

The affected product is distributed nationwide and in Ghana. The specific lot code is EBSI1021 VALVE CHANGE KIT- DOUBLE2019050680.

Consumers and healthcare providers should stop using the affected product and contact Centurion Medical Products Corporation for instructions on return or replacement.

The recalled product

Product
Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE

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: EBSI1021 VALVE CHANGE KIT- DOUBLE2019050680

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 →