The FDA announced on Aug. 1, 2022, that CAREFUSION is recalling BD MaxGuard Drop Administration sets due to incorrect expiration date labeling. The agency said the error could compromise product integrity and pose a risk of infection.
How to tell if you have it
- Brand: CAREFUSION
- Product: BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock
- REF: MX4436
- UDI-DI: 10885403237478
- Lots: 22019074, 22019431, 22019075, 22019076
- Quantity: 19,925 units
The hazard
The FDA said the product labels list an expiration year of 2027 instead of the correct 2025. If expired product is used, the integrity of the product may be compromised and may result in potential leaks and risk of infection to the patient and healthcare worker.
Context
GovInfoNow's records show CAREFUSION has two other recalls on record since June 9, 2021. On Aug. 2, 2021, CAREFUSION recalled SmartSite Products that may cause flow issues due to needle-free connector valve problems. On June 9, 2021, CAREFUSION recalled MaxPlus bi fuse extension sets because a validation lot failed leakage testing criteria. Other recent recalls of similar products include BD Ready-to-Use Hydrophilic Catheter 14 Fr (Nov. 29, 2025) and Cook Staged Extubation Set (March 5, 2026).