Z-0958-2021Class II

154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER -

Name: Z-0958-2021 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER -
Creator: ICU Medical, Inc.
Published: 2020-12-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-12-02 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 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... on 2020-12-02. FDA classified it as Class II and gives the reason as "Due to the incorrect filter assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0958-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Posted: 2021-02-05
Terminated: 2023-06-30
Recalling firm: Abbott Medical
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).
Product code: FMG Stopcock, I.V. Set
Reason for recall: Due to the incorrect filter assembly.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-0956-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-0957-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05
Z-0958-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)