Agency classClass IIOur severity:High FDA (Devices)·Z-1754-2022·Announced 2022-09-28

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.

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 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
Affected units: 54,050

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:

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 →

Same manufacturer · CAREFUSION

See all →

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BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
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Same hazard · leakage