BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.
What this means for you
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 a Class II FDA recall for a medical device with potential for patient harm through infection risk if expired products are used. No illnesses or injuries have been reported. Per the severity rubric, this constitutes a 'High' (3) severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
CAREFUSION has recalled 600 units of the BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site (REF: MX9166, Lot 22029648). The affected product labels incorrectly list the expiration year as 2027 when it should list 2025.
If expired products are used in clinical settings, the integrity of the administration set may be compromised. This could result in potential leaks that pose a risk of infection to both patients and healthcare workers.
The recalled units were distributed across multiple U.S. states. Healthcare facilities that have received this product should check for the affected lot number and verify the correct expiration date. Facilities should cease use of any units with the incorrect labeling and contact CAREFUSION for replacement or return information.
The recalled product
- Product
- BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
- Manufacturer
- CAREFUSION
- Hazard
- mis-labeling
- infection-risk
- leakage
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: 10885403237652
- Lots: 22029648
Distribution
Distributed in 39 states:
- AL
- AR
- AZ
- CA
- CO
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- NC
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WV
- WY
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