Device recall
IV Non-Dedicated Gravity Administration Sets with drip chambers
- Recall number
- Z-3157-2026
- Event id
- 99058
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- ICU Medical, Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 11, 2026
- Initiated
- May 12, 2026
- Center classification date
- Sep 11, 2026
- Product code
- FMG
- Device type
- Stopcock, I.V. Set
- Reason
- 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.
- Root cause
- Process control
- Quantity
- 2,450
- Code info
- All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K964435
- Location
- San Clemente, CA, United States