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.
Reported: September 26, 2018 Initiated: July 13, 2018 #Z-3196-2018
Product Description
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.
Reason for Recall
The product was mislabeled with the incorrect label.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 29,600 kits
- Distribution
- US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product 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.. Recalled by Smiths Medical ASD Inc.. Units affected: 29,600 kits.
Why was this product recalled? ▼
The product was mislabeled with the incorrect label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Low. Recall number: Z-3196-2018.
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