Centurion Medical Products Recalls Sterile Cap Change Kits
Centurion Medical Products is recalling sterile cap change kits because they include a connector that may leak 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 leakage, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling sterile cap change kits (model DYNDC1946B) because they include the BD MaxZeroNeedleess Connector. The connector was previously recalled by its manufacturer due to a potential for droplets of fluid to separate from the sealed surface following disconnection.
The recall covers 181,965 units distributed nationwide. The affected lots have codes 2018101790, 2018092790, and 2019030690.
Healthcare facilities and consumers should stop using these kits and contact Centurion Medical Products Corporation for instructions on return or replacement.
The recalled product
- Product
- STERILE CAP CHANGE KIT DYNDC1946B
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- 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)
- 2018101790 2018092790 2019030690
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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