FDA-Device2018-09-26Class III
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Smiths Medical ASD Inc.
Hazard
The product was mislabeled with the incorrect label.
Sold states
US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Affected count
29,600 kits
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3196-2018Don't want to check this manually?
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