Dear Valued Customers:
ICU Medical, Inc. is issuing this Urgent Medical Device Recall letter to notify you of a potential for leaks to occur with the Spinning Spiros™ Male Luer in certain lots. The attached urgent medical device recall letter details the issue and the required steps for you to perform.
ICU Medical has identified the potential for certain lots of the Spinning Spiros to exhibit leaks due to a molding defect. This information pertains to the spinning version of the Spiros only. The non-spinning version is not affected by this communication.
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. ICU Medical has received reports of leaks potentially related to this issue and has not received reports of permanent injury or death.
Affected products were distributed in the United States between January 2020 and July 2020. The affected item and lot numbers are provided in Table 1 of the attached recall letter.
If you have any questions regarding this recall, please contact your IMS Sales Representative or call Customer Service at 800-755-3800.