medical Class II Updated 2020-12-30

ICU Medical, Inc. recalls Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG

Recalled Product

Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763


Hazard / Issue

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: 4605964, 4764534, 4903199, 4901115, 4849120, 4865839, 4895024, 4603209, 4866030
View official government recall

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