Carefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets due to leakage defects. The affected units failed validation testing for leakage and were inadvertently released to the Tennessee market.
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: This is an FDA Class II device with no reported illnesses or injuries. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' which corresponds to severity score 3 (High). A leakage defect in a sterile medical infusion connector represents a direct risk of contamination or improper drug delivery.
Plain-English summary
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets with 2 clear needleless connectors (Catalog Number MP9246-C, Lot Number 20087194). These devices are used for direct injection, intermittent infusion, continuous infusion, or aspiration in medical settings.
A portion of the validation lot was inadvertently released to the market without meeting the required validation testing criteria regarding leakage. The affected units do not meet quality standards for leakage performance.
Approximately 100 units were distributed in Tennessee. Consumers and healthcare providers in possession of this product should immediately cease use and contact their healthcare provider or Carefusion for further guidance on replacement or disposal.
The recalled product
- Product
- MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
- Manufacturer
- CAREFUSION
- Affected units
- 100
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)
- Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · CAREFUSION
See all →- HighBD MaxGuard Extension Set Recalled for Incorrect Expiration Year
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
FDA (Devices) · 2022-09-28
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighCareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks
FDA (Devices) · 2017-03-22
- SevereBecton Dickinson Recalls CareFusion MaxPlus Clear Needleless Connectors
FDA (Devices) · 2019-10-16
- HighCareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports
FDA (Devices) · 2017-03-22
- HighBD SE Burette Set needle-free connectors recalled for flow obstruction risk
FDA (Devices) · 2021-09-22
- HighCareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage
FDA (Devices) · 2015-11-11
- HighBD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
FDA (Devices) · 2022-09-28