FDA Device recall Z-0700-2021

Spinning Spiros, Closed Male Luer, REF: 060-CH2000S

• FDA Device
• Class II
• ongoing
• Published 2020-12-30

On 2020-12-30 the FDA classified a Class II recall of Spinning Spiros, Closed Male Luer, REF: 060-CH2000S by Icu Medical, citing 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, exp….

Read the official FDA Device notice

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

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0700-2021%22

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