BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date
BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.
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: FDA Class II recall for a medical device with risk of patient and worker infection from potential leaks if expired product is used, but no illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
BD MaxGuard Extension Set, Reference Number ME1069, manufactured by CareFusion, is being recalled due to a labeling error. Approximately 3,500 units with lot number 22019062 have product labels that incorrectly list 2027 as the expiration year instead of the correct expiration year of 2025. This labeling error affects healthcare facilities across multiple US states.
Using expired medical devices may compromise the integrity of the product, potentially resulting in leaks during clinical use. These leaks could increase the risk of infection to patients and healthcare workers relying on the device. If you have received units with expiration year 2027 labeled on the packaging, they should be considered recalled and removed from service.
Healthcare facilities should verify the expiration dates on all BD MaxGuard Extension Set units in their inventory. Any units labeled with expiration year 2027 should be set aside and not used. Contact CareFusion for instructions on how to return the recalled units or obtain replacements.
The recalled product
- Product
- BD MaxGuard Extension Set, REF: ME1069
- Manufacturer
- CAREFUSION
- Category
- Medical Device
- Hazard
- mislabeled-expiration
- leak-risk
- infection-risk
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: 10885403236037
- Lots: 22019062
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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