Centurion Medical Central Line Bundle Recalled for Fluid Droplet Risk
Centurion Medical is recalling central line bundles containing a BD MaxZeroNeedleess Connector due to the potential for fluid droplets to separate from the sealed surface after disconnection.
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 with a potential for fluid separation, which poses a risk of harm (such as infection or exposure) even though no injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545 units. The recall involves 181,965 total units that were distributed nationwide. The product includes the BD MaxZeroNeedleess Connector, which was recalled by its manufacturer due to a specific defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is associated with the specific connector component included in the kits.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Central Line
- 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)
- 2018102950 2018110250
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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