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Open, Classified

Oncology sets with drip chambers

FDA Recall Z-3159-2026 · Posted 2026-09-11

Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeONB
Date Initiated2026-05-12
Product Quantity28,550

Reason for Recall

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Firm Action

On 5/12/2026, the firm posted a Information Regarding Reported Black Specks in Certain IV Tubing Set Drip Chambers from ICU Medical document on their website. On 5/18/2026, updated the notices were sent. On 7/28/2026, correction notices were sent to customers asking them to do the following: 1) Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used or further distributed to another location, please ensure that this communication is delivered there. 2) Complete and return the attached Customer Response Form to [email protected] 3) Continue using products as intended and per facility protocol. 4) Report any product quality concerns to ICU Medical Complaint Management. Firm contacts: [email protected] 1-866-261-8806. [email protected] 1-800-258-5361

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc. · 2018-08-31K131549CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc. · 2013-07-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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