ICU Medical, Inc.: REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: 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-1584-2021

Recalling firm

ICU Medical, Inc.

Product

REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: 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

Open, Classified

Initiated

2021-03-16

Posted

not on file

Terminated

not on file

Reason

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Root cause

Component design/selection

Action

On 03/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL " Letter via Stericycle, Inc. informing customers that it has identified the potential for certain lots of Spiros to exhibit small amounts of leaks due to a molding defect. Customer are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check their inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their 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 the customer does not have the affected product. 3) The Recalling Firm has some lots of unaffected product available today and is actively increasing the amount of available inventory. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-300-2207 (MF, 8am-5pm ET) if customers have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Do not reproduce. Customers can 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 customers for any product returned. Customers will only receive credit for product that are returned. NOTE: Credits for product purchased through distributor will be credited by the distributor. 5) If customers have distributed the product further, immediately notify those accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-300-2207 (M-F, 8am-5pm ET) to obtain a response form. For

Quantity

not on file

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Lot, serial or model codes

REF: 034-H2629  UDI: (01) 1 0840619 07938 0 (17) 260101 (30) 50 (10) 5125301  Lot Number: 5125301

510(k) numbers

not on file

PMA numbers

not on file

Product code

N/A

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

Copy