ICU Medical, Inc. 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
Lots: 4727479, 4784305
Products Sold
Lots: 4727479, 4784305
ICU Medical, Inc. is recalling 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiro due to Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contami. Based on FDA medical device recall database.
Summary derived from FDA notice
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026