Centurion Medical Recalls Infusa Port Kits Due to Fluid Droplet Risk
Centurion Medical Products Corporation is recalling Infusa Port Kits containing a specific 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. The hazard involves a risk of harm (fluid separation) in a medical device where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling Infusa Port Kits (model DYNDC1840F) because they include the BD MaxZeroNeedleess Connector. This specific connector was previously recalled by its manufacturer due to a defect where droplets of fluid may separate from the sealed surface of the connector following disconnection.
The recall involves 181,965 units of the Infusa Port Kit DYNDC1840F. These products were distributed nationwide in the United States. The affected lots are identified by the following codes: 2018092090, 2018100890, 2018122890, and 2019032790.
Healthcare providers and consumers should stop using the affected Infusa Port Kits immediately. Centurion Medical Products Corporation is the recalling firm responsible for managing this recall. Users should contact the manufacturer for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- INFUSA PORT KIT DYNDC1840F
- 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)
- 2018092090 2018100890 2018122890 2019032790
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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