FDA-Device2013-07-03Class II
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
Baxter Healthcare Corp.
Hazard
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
Sold states
Distributed Nationwide and in Puerto Rico.
Affected count
3,255,096 total
Manufactured in
Route 120 And Wilson Rd, Round Lake, IL, United States
Products
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2013Don't want to check this manually?
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