Centurion Triple Lumen Bundle Kit Recalled for Fluid Droplet Risk
Centurion Medical Products is recalling Triple Lumen 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 medical device defect (fluid droplets) that 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 where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the TRIPLE LUMEN BUNDLE KIT ECVC1540. The recall involves 181,965 units that were distributed nationwide. The kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer due to a specific defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is associated with the specific connector component included in the bundle kits.
Healthcare facilities and consumers who have these kits should stop using them and contact Centurion Medical Products Corporation for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRIPLE LUMEN BUNDLE KIT ECVC1540
- Manufacturer
- Centurion Medical Products Corporation
- 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
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · fluid contamination
See all →- HighB. Braun dispensing pins recalled for air filter leakage risk
FDA (Devices) · 2022-03-16
- HighCenturion Medical Recalls Sorbaview IV Kits Due to Fluid Droplet Risk
FDA (Devices) · 2019-10-16
- HighCenturion Medical Products Recalls CAP CHANGE KIT DYNDC1496B
FDA (Devices) · 2019-10-16
- HighCenturion Neonatal Procedure Tray Recall Due to Connector Fluid Droplet Risk
FDA (Devices) · 2019-10-16
- HighCenturion Pediatric PICC Insertion Tray Recalled for Connector Fluid Droplet Risk
FDA (Devices) · 2019-10-16
Similar recalls
- SevereCenturion Multi-Med Single Lumen Catheters Recalled for Embolism Risk
FDA (Devices) · 2016-12-14
- HighMedline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects
FDA (Devices) · 2024-08-14
- HighCenturion Convenience Kits Recalled Due to Cracking IV Connector Threads
FDA (Devices) · 2016-03-02
- HighChurchill Medical Systems Recalls 4-inch Microbore Double Lumen Sets
FDA (Devices) · 2015-04-29
- HighCenturion Recalls Convenience Kits Contaminated with Particulate Matter
FDA (Devices) · 2018-01-10
- HighCenturion Clamp kits recalled due to potential sterility breach risk
FDA (Devices) · 2024-04-10