FDA-Device2023-11-01Class II
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Smiths Medical ASD Inc.
Hazard
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
Sold states
US
Affected count
31900 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2024Don't want to check this manually?
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