Centurion IV Start Kits Recalled Due to Fluid Droplet Risk
Centurion Medical Products is recalling IV Start Kits containing a recalled BD connector due to potential fluid droplet separation.
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 recall involves a medical device with a potential for fluid exposure (risk-of-harm product) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling IV Start Kits (IV8440) because they include the BD MaxZeroNeedleess Connector. This specific connector component was previously recalled by its manufacturer due to a defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. The recall covers 181,965 units that were distributed nationwide.
Healthcare facilities and distributors should stop using the affected kits and follow instructions from the recalling firm or the FDA regarding the return or destruction of the product.
The recalled product
- Product
- IV START KIT IV8440
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Supplies
- Affected units
- 181,965
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.
See all 33 products in this recall →Related recalls
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