Centurion Infusa Port Kit Recalled for Fluid Droplet Risk
Centurion Medical Products is recalling Infusa Port Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.
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 is classified as FDA Class II and involves a medical device with a risk of fluid separation, which poses a potential risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling the INFUSA PORT KIT DYNDC1840E. The recall involves 181,965 units that were distributed nationwide. The kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer.
The reason for this recall is the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is associated with the specific BD connector component included in the kit.
No specific instructions for consumers are provided in the source text. The recall is classified as Class II by the FDA.
The recalled product
- Product
- INFUSA PORT KIT DYNDC1840E
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Infusion Port
- Hazard
- 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)
- 2018081790
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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