—#184959

Product

7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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).

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435
Affected lot / code info: Model List Number: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091

Why it was recalled

Due to the incorrect filter assembly.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-12-02
Terminated: 2023-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184959. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.