[Recalled] BodyGuard Microset, REF: A100-163XSL — Infusion administration sets may have a delivery inaccuracy over plus/minus 13%… | FDA 2020-06-16

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from CME America, LLC

• CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural — Class II
• BodyGuard Microset, REF: A120-161XPS — Class I
• BodyGuard Microset With Female Luer, REF: A120-160XPSN — Class I
• BodyGuard Microset, REF: A120-160X2YB — Class I
• 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. — Class I
• BodyGuard BodySet, REF: A120-160SAS — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.