Z-3158-2026 Class II Ongoing
FDA device recall Z-3158-2026 was initiated by ICU Medical, Inc. on May 12, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 107,800.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107,800
Product Description
Oncology sets with drip chambers
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.
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.
Code Information
All products manufactured on or before 7/4/2026. UDI-DI: 10840619054486, 10887709091914