Centurion Medical CVC Safety Bundle Recalled for Connector Fluid Leakage
Centurion Medical Products is recalling CVC Triple Lumen Safety Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.
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 FDA Class II classification indicates a risk of temporary or medically reversible adverse health consequences, and the potential for fluid leakage from a medical connector represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC Triple Lumen Safety Bundles (ECVC6070) due to a defect in the included BD MaxZeroNeedleess Connector. The connector has the potential for droplets of fluid to separate from the sealed surface following disconnection.
The recall covers 181,965 units distributed nationwide. The affected lots are identified by codes 2018081550, 2018091750, and 2018100850. The FDA has classified this as a Class II recall, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected bundles and contact Centurion Medical Products Corporation for instructions on returning or disposing of the product. Patients who have received care using these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 181,965
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)
- 2018081550 2018091750 2018100850
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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.
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