Centurion Medical Recalls Neonatal Cap Change Kits Due to Fluid Droplet Risk
Centurion Medical Products Corporation is recalling Neonatal Cap Change Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets 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 defect that poses a risk of harm (fluid droplets) but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the Neonatal Cap Change Kit DT20315. The recall involves 181,965 units that were distributed nationwide. The kits include 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 was identified by the manufacturer of the connector component.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the product or return it. Users should refer to official FDA or manufacturer communications for specific instructions on handling the recalled items.
The recalled product
- Product
- Neonatal Cap Change Kit DT20315
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Neonatal Care
- 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)
- 2017042480 2017061980 2017082880
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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