BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk 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 medical device with documented risk of harm (potential leaks and infection from use of expired product) where no injuries or illnesses have yet been reported, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
CAREFUSION is recalling the BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites (REF: MX9433) due to a labeling defect. Product labels incorrectly list the expiration year as 2027 when the correct expiration year is 2025.
If expired product is inadvertently used in clinical settings, the integrity of the product may be compromised, potentially resulting in leaks and increasing the risk of infection to both patients and healthcare workers.
Approximately 9,900 units were distributed across multiple states under lot number 22019085. Healthcare facilities and providers who received this product should check their inventory immediately to identify affected units and discontinue use of any that have reached or exceeded the correct 2025 expiration date.
The recalled product
- Product
- BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
- Manufacturer
- CAREFUSION
- Hazard
- expiration-mislabeling
- leakage-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: 10885403237782
- Lots: 22019085
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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