Reported Mar 18, 2020 · Terminated
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The…
CME America, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 REF A120-003XYVA, Sterile EO
- Tubing150 in. (380 cm)
- Prime Volapprox. 8ml
- Product UsageThe BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously
- Lot codes and dates
- Catalog NumberA120-003XYVA
- UDI00818666020146
- Lot Numbers
106361065312117128361315613279136561397814057141881454514790149661507319486194901949219834161731496615073152771543415802
- Amount recalled
- 69400 infusion sets
Where it was sold
Why it was recalled
Stop using this product now
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Using this product could cause serious injury, illness or death — stop using it now.
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