Smiths Medical ASD product recalled over labeling errors
- Recall date
- July 13, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Smiths Medical ASD Inc. recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile,…
- Recall number
- Z-3196-2018
- FDA classification
- Class III
- Brand / firm
- Smiths Medical ASD Inc.
- Sold / distributed
- US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Why it was recalled
The product was mislabeled with the incorrect label.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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