ICU Medical, Inc. 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428
ICU Medical, Inc. is recalling 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular admi due to Due to the incorrect filter assembly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to the incorrect filter assembly.
Recommended Action
Per FDA guidance
On 12/02/2020, the firm's third party contractor send an "URGENT: MEDIAL DEVICE RECALL" Notification letter via traceable mailing to direct and indirect consignees informing them that specific lots of IV extension sets that may contain an incorrect filter assembly of a 0.2 micron filter instead of a 1.2 micron filter and the potential hazards/risks potentially cause delay in therapy or under delivery of medication. Customers are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their organization of the notification and to complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if customer do not have the affected product. 3) Return affected product using the return label provided with the letter. Contact Stericycle at 1-888-243-5547 (MF, 8am-5pm ET) if they have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Please do not reproduce. Visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, the Recalling Firm will credit you for any product returned. Customers will only receive credit for product that they return. NOTE: Credits for product purchased through distributor will be credited by the distributor. 4) If customers have distributed the product further, immediately notify the accounts that received the product identified in the Affected Product section of this notification and ask them to contact Stericycle at 1-888-243-5547 (M-F, 8am-5pm ET) to obtain a response form. For further inquiries, please contact the Recalling Firm usi
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