Recall Z-3158-2026 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
Oncology sets with drip chambers
| Date | Sep 11, 2026 (initiated May 12, 2026) |
| Status | Open, Classified |
| 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 |
| 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 M |
| Quantity | 107,800 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081361 | CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX Icu Medical, Inc., Aug 28, 2008 |