Centurion Medical Products Recalls CAP Bundle Kits Due to Fluid Droplet Risk
Centurion Medical Products is recalling CAP Bundle 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 is classified as FDA Class II and involves a risk of fluid exposure (potential contamination or infection) without reported 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 CAP Bundle Kits (DYNDC2137) due to a defect in the BD MaxZeroNeedleess Connector included in the kits. The manufacturer of the connector identified a potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The recall involves 181,965 units distributed nationwide. The affected product codes are 2018091390 and 2018120590. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using the affected CAP Bundle Kits and contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- CAP BUNDLE KIT DYNDC2137
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical 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)
- 2018091390 2018120590
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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