Reported May 13, 2020 · Terminated
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage:…
CME America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CME America, LLC · 14998 W 6th Ave Ste 830 · Golden, CO · 80401-5025
Is this the product you have?
- BodyGuard Microset For Use with the BodyGuard Infusion Pump ***
- Tubing110 in. (280
- cm) - Blue Stripe - Product UsageThe system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments
- Lot codes and dates
- Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201
- Amount recalled
- 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Where it was sold
Why it was recalled
The filter installed onto the tube set may have the incorrect pore size.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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