- The U.S. Food and Drug Administration (FDA) on Wednesday classified the recall of some syringe infusion pumps by ICU Medical ( NASDAQ: ICUI ) company Smiths Medical as the most serious type.
- Smiths Medical in April recalled over 118K of its Medfusion 4000 and 3500 Syringe Infusion Pumps distributed between Oct. 2004 to Feb. 17, 2022.
- Smiths recalled the pumps after highlighting eight software malfunctions that may impact infusion delivery or cause delay in the delivery of critical medication.
- The FDA classified the recall Class I , the most serious type as per its rules. Smiths said there had been a total of seven serious injuries and one death reported related to the issues with the pumps.
- ICUI stock earlier closed +1.4% at $171.29.
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FDA labels ICU Medical unit's April recall of syringe infusion pumps as most serious