CME America, LLC: BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance me

Is my product affected?

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environm

• UPC 10818666020013
• UPC 10818666020006

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

What happened

CME America, LLC is recalling BodyGuard Microset tubing sets for use with BodyGuard Infusion Pumps due to filters that may have an incorrect pore size. The recall affects approximately 30,300 units total: 5,800 units from lot 90829 and 24,500 units from lot 16201. These products were distributed nationwide across the United States, including in Alaska, California, Illinois, Kansas, Massachusetts, Missouri, and South Dakota.

The recall notice does not specify a remedy or instructions for what affected consumers should do.

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

Hazard

The filter installed onto the tube set may have the incorrect pore size.

Details from the source

Reason for recall: The filter installed onto the tube set may have the incorrect pore size. Distribution: US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S. Quantity: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201 Lot/code info: Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201

Source

Official record: FDA (Device enforcement) ↗

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

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