BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.
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: FDA Class II recall with theoretical infection and leakage risk from expiration dating error; no reported illnesses or injuries. Risk-of-harm product without confirmed incidents scores as High per rubric.
Plain-English summary
CAREFUSION is recalling BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site (REF: MX9171, Lot 22029674) due to a labeling error. The product labels list an expiration year of 2027, but the correct expiration year is 2025.
If expired product is used, the integrity of the product may be compromised, which could result in potential leaks and infection risk to patients and healthcare workers.
The affected product was distributed to healthcare facilities in multiple U.S. states. Healthcare providers and facilities should verify the correct expiration date and discontinue use of any units that have expired.
The recalled product
- Product
- BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
- 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 (2)
- UDI-DI: 10885403237669
- Lots: 22029674
Distribution
Part of a larger recall action
This product is one of 9 recalled by CAREFUSION 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 9 products in this recall →Related recalls
Same manufacturer · CAREFUSION
See all →- HighBD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
FDA (Devices) · 2022-09-28
- HighBD MaxGuard Extension Set Mislabeled With Wrong Expiration Date
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 Extension Set Mislabeled with Wrong Expiration Year
FDA (Devices) · 2022-09-28
Same hazard · infection risk
See all →- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighCareFusion Recalls MaxGuard Extension Sets Due to Filter Leaks
FDA (Devices) · 2017-03-22
- HighCareFusion Recalls MaxGuard Extension Sets Due to Leakage Reports
FDA (Devices) · 2017-03-22
- HighBD SmartSite Needle-Free Valve Extension Set Recalled for Potential Occlusion
FDA (Devices) · 2021-09-22
- HighCarefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect
FDA (Devices) · 2021-07-07
- HighBD PhaSeal Y-Site Connector recalled for mislabeled expiration dates
FDA (Devices) · 2022-08-24
- HighBD Medical Extension Sets Recalled for Potential Sterilization Defects
FDA (Devices) · 2026-08-19