FDA-Device2014-02-26Class II
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
B. Braun Medical, Inc.
Hazard
Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.
Sold states
Nationwide Distribution.
Affected count
2,357,944
Manufactured in
901 Marcon Blvd, Allentown, PA, United States
Products
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0987-2014Don't want to check this manually?
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