BD MaxGuard Extension Set labeled with incorrect expiration year 2027
46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking 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: This is an FDA Class II device recall involving a labeling error that could result in use of expired medical equipment with potential for leaks and infection risk. Although no illnesses or injuries have been reported, the product poses a direct risk of harm if used after the actual expiration date, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD CAREFUSION has recalled 46,900 BD MaxGuard Extension Sets with 4-way stopcock (REF: M4058) due to incorrect expiration dates printed on product labels.
The product labels list an expiration year of 2027, but the correct expiration year is 2025. If expired product is used in clinical settings, the integrity of the extension set may be compromised, potentially resulting in leaks. Such failures could pose a risk of infection to both patients and healthcare workers.
The recalled lots include 22019324, 22019323, and 22019322 (UDI-DI: 10885403235788). Affected units were distributed across 40 U.S. states and territories. Healthcare facilities and medical professionals should immediately identify and cease use of these affected lots and contact CAREFUSION for guidance on return or replacement procedures.
The recalled product
- Product
- BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
- Manufacturer
- CAREFUSION
- Hazard
- expiration-mislabeling
- 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 (4)
- UDI-DI: 10885403235788
- Lots: 22019324
- 22019323
- 22019322
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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