ICU Medical, Inc.: 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - 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 number

Z-0955-2021

Recalling firm

ICU Medical, Inc.

Product

60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - 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).

Status

Terminated

Initiated

2020-12-02

Posted

not on file

Terminated

2023-06-30

Reason

Due to the incorrect filter assembly.

Root cause

Process control

Action

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

Quantity

Total Kits = 7,500 for all four lots

Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.

Lot, serial or model codes

Model List Number: B2209 UDI: (01)10887709085439(17)250401(30)50(10)4794177 Lot Number: 4794177

510(k) numbers

["K964435"]

PMA numbers

not on file

Product code

FMG

Firm FEI

2025816

Firm city

San Clemente

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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