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FDA (Device enforcement)Recalled 2022-08-01class ii

CAREFUSION: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106

Is my product affected?

BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106

  • UPC 10885403236358

Check against the official notice below — it lists the full affected range.

What happened

CareFusion is recalling 54,050 BD MaxGuard Flow Controller Extension Sets with Needleless Y-Site (REF: MFS106) distributed across 43 states. The product labels incorrectly list the expiration year as 2027 when it should be 2025. The affected lots are 22019311, 22019312, 22019313, and 22019314.

If expired product is used, the integrity of the administration and extension sets may be compromised, potentially resulting in leaks and creating a risk of infection to both patients and healthcare workers. The source record does not specify what remedy consumers or healthcare facilities should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

Details from the source

Reason for recall: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker. Distribution: US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN Quantity: 54,050 Lot/code info: UDI-DI: 10885403236358, Lots: 22019311, 22019312, 22019313, 22019314

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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