ICU Medical, Inc. 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Dri Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. 5) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle to obtain a response form. For further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service, 1-866-829-9025, option 8 or, customerservice@icumed.com, (M-F, 8am-6pm CT) On 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.