BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year
BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create 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: FDA Class II recall with no reported injuries or illnesses. The hazard is theoretical—use of expired product could compromise device integrity and increase infection risk—but represents a clear risk-of-harm scenario without reported harm, meeting the rubric criterion for High severity.
Plain-English summary
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site (REF: MFS106), manufactured by CAREFUSION, is being recalled due to a labeling error. Product labels incorrectly state an expiration year of 2027 when the correct expiration year is 2025. Approximately 54,050 units with lot numbers 22019311, 22019312, 22019313, and 22019314 are affected. The product has been distributed across multiple US states.
If expired product is used in clinical settings, the device integrity may be compromised. This can result in potential leaks and an increased risk of infection to both patients and healthcare workers.
Healthcare facilities and providers who may have this product in inventory should identify and remove affected lots from use. Contact CAREFUSION or the FDA for information regarding replacement, return, or proper disposal of the recalled product.
The recalled product
- Product
- BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
- Manufacturer
- CAREFUSION
- Category
- Medical Device — Infusion Sets
- Hazard
- leakage
- infection-risk
- product-integrity-compromise
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 (5)
- UDI-DI: 10885403236358
- Lots: 22019311
- 22019312
- 22019313
- 22019314
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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