BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates
CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.
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 medical device with risk of infection from potential product integrity compromise due to incorrect expiration date. No hospitalizations or injuries are reported; the hazard is theoretical, placing this at the maximum score for theoretical risks without reported harm.
Plain-English summary
CAREFUSION is recalling BD MaxGuard Extension Set with 2 Needleless Y-Site (REF: MX9059) due to incorrect product labeling. The labels for 17,250 units list expiration year 2027, when the correct expiration year is 2025. Affected lot numbers are 22029431 and 22029432.
Use of expired extension sets may compromise product integrity, potentially resulting in leaks. Compromised product integrity and leaks pose a risk of infection to both patients and healthcare workers.
The recalled units have been distributed to healthcare facilities across multiple U.S. states. Healthcare providers should identify any BD MaxGuard Extension Sets with the affected lot numbers in their inventory and verify the expiration date shown on the product label.
The recalled product
- Product
- BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
- Manufacturer
- CAREFUSION
- Hazard
- infection-risk
- expired-product
- integrity-compromise
- labeling-error
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 (3)
- UDI-DI: 10885403237584
- Lots: 22029431
- 22029432
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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