Centurion Medical Products Recalls Triple Lumen CVC Kits Due to Connector Defect
Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface 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, which indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard involves fluid leakage from a medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 181,965 units of TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040 kits. These kits were distributed nationwide in the United States. The recall is associated with recall number Z-0106-2020.
The recall is being conducted because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is classified as an FDA Class II recall.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement. The affected lots are identified by the following codes: 2018110150, 2018120350, 2018121050, 2019021150, and 2019021550.
The recalled product
- Product
- TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
- 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)
- 2018110150 2018120350 2018121050 2019021150 2019021550
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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