Recall archive
7 recalls · page 1 of 1
Reported Dec 9, 2020
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CME America, LLC
Matched: Brand · Product · Product details — Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated.…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2020
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CME America LLC
Matched: Brand · Product · Product details — The wall charger may not properly charge the infusion pump battery.
FDA (openFDA device enforcement)
Reported Jul 22, 2020
BodyGuard BodySet, REF: A120-160SAS
High riskUsing this product could cause serious injury, illness or death — stop using it now.CME America, LLC
Matched: Brand — 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…
36 more products in this recall
FDA (openFDA device enforcement)
Reported May 13, 2020
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CME America, LLC
Matched: Brand — The filter installed onto the tube set may have the incorrect pore size.
FDA (openFDA device enforcement)
Reported Mar 25, 2020
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CME America, LLC
Matched: Brand · Product · Product details — Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very…
FDA (openFDA device enforcement)
Reported Mar 18, 2020
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CME America, LLC
Matched: Brand — When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
FDA (openFDA device enforcement)
Reported Feb 25, 2015
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CME America, LLC
Matched: Brand · Reason for recall — CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
FDA (openFDA device enforcement)
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