BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 theoretical risk of harm (potential leaks and infection if expired product is used) but no reported illnesses or injuries. Meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CAREFUSION is recalling the BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock (REF: MX4436). The recall affects 19,925 units from lot numbers 22019074, 22019431, 22019075, and 22019076.
The product labels list expiration year 2027, but the correct expiration year is 2025. If expired administration sets are used, the product's integrity may be compromised, potentially resulting in leaks and creating a risk of infection to both patients and healthcare workers.
The affected product was distributed to healthcare facilities across the United States. This is a Class II recall.
The recalled product
- Product
- BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
- Manufacturer
- CAREFUSION
- Affected units
- 19,925
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: 10885403237478
- Lots: 22019074
- 22019431
- 22019075
- 22019076
Distribution
Part of a larger recall action
This product is one of 9 recalled by CAREFUSION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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