Icu Medical, Inc.: Stopcock, I.v. Set
Summary ICU Medical is recalling certain IV tubing sets because black specks and particulate matter have been found in the drip chamber. The affected products are IV tubing sets distributed by ICU Medical. This recall applies to patients and healthcare facilities that use these tubing sets.
- Recalling firm
- ICU Medical, Inc.
- Product
- IV Sets with drip chambers
- 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. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/248e593d-5563-41b3-846c-f93a173a4328