Urgent Medical Device Recall: MicroClave® Clear Connector

ICU MEDICAL MICROCLAVE® CLEAR CONNECTOR RECALL NOTICE

ICU Medical, Inc. has issued an Urgent Medical Device Recall letter regarding a potential defect with the MicroClave Clear connector.

ISSUE:

ICU Medical has identified the potential for a manufacturing defect within specific lots of MicroClave Clear sets, which may result in a visible gap between the MicroClave Clear connector's top and bottom housings.

POTENTIAL RISK:

Inadequate connection between the MicroClave Clear connector's top and bottom housings may potentially cause or lead to delayed delivery of infusion solution during setup/infusion, fluid break, blood loss/exposure to patient blood, air embolism, exposure to allergenic/caustic substances, or fluid path contamination. To date, ICU Medical has not received any reports of serious injury or death associated with this issue.

Actions Required:

1. 1. REVIEW your inventory for affected product.
   2. SEGREGATE and QUARANTINE all on-hand product per the Items Impacted table above. 
   3. COMMUNICATE this notice to clinical staff through safety huddles to ensure awareness of this product issue.  
   4. CONTACT your IMS Sales Representative or Customer Service to discuss next steps for product returns.

Please review the required actions by ICU Medical for complete details.