CME America, LLC: BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication

Is my product affected?

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

• UPC 00818666020146

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

What happened

CME America, LLC is recalling 69,400 BodyGuard Microset infusion tubing sets (Catalog Number A120-003XYVA) due to a hazard where the tubing may cause under-delivery of fluids when used with the BodyGuard Infusion Pump System. The affected product is sterile tubing measuring 150 inches with a prime volume of approximately 8 milliliters. The recalled tubing sets were distributed in California, Ohio, Pennsylvania, Texas, and Canada, and are identified by specific lot numbers ranging from 10636 to 19834.

The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Details from the source

Reason for recall: When using a specific tubing set with infusion pump system, may result in under deliver of fluids. Distribution: US: CA, OH, PA, and TX OUS: Canada Quantity: 69400 infusion sets Lot/code info: Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802

Source

Official record: FDA (Device enforcement) ↗

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

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