Centurion Medical Recalls Sorbaview IV Kits Due to Fluid Droplet Risk
Centurion Medical Products Corporation is recalling Sorbaview IV kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
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 droplet separation, which poses a risk of harm (such as infection or contamination) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling Sorbaview IV kits (IVS3475) due to a defect in the BD MaxZeroNeedleess Connector included in the kits. The manufacturer of the connector recalled it because fluid droplets may separate from the sealed surface of the connector following disconnection.
The recall covers 181,965 units distributed nationwide. The affected lots are identified by the following codes: 2019031490, 2018070690, 2018100290, 2018100390, 2018121390, and 2019020690.
Healthcare facilities and consumers should stop using the affected IV kits and contact Centurion Medical Products Corporation for instructions on returning the product.
The recalled product
- Product
- IV KIT - SORBAVIEW IVS3475
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Kits
- 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)
- 2019031490 2018070690 2018100290 2018100390 2018121390 2019020690
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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