FDA-Device2026-09-23Class IIPROCESSING DEFECT

ICU Medical Plum administration sets recalled for black specks in drip chambers

OTHERNationwide distributionMedical devices

What this means

ICU Medical's Plum intravascular administration tubing sets may contain black specks in the drip chamber. The specks appear to be discolored PVC material from the manufacturing process. Particulate matter could potentially enter the fluid path.

Check your Plum administration set drip chamber for black specks or discoloration
If you see black specks, do not use the set
Contact your healthcare facility or ICU Medical with the product's UDI-DI number for instructions on replacement or return
Review the full list of affected UDI-DI numbers on the FDA website to confirm if your product is included

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

163,500,199

Manufactured in

951 Calle Amanecer, N/A, San Clemente, CA, United States

Products

Plum administration sets

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3156-2026

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