ICU Medical Inc: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.

Is my product affected?

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787009259
• UPC 10887787009252

Check against the official notice below — it lists the full affected range.

What happened

ICU Medical Inc. is recalling Sapphire Microbore Infusion Sets with Inline Filters, specifically those labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore. The recalled products have product code 240100401 and specific lot numbers: 897525H, 905915H, and 926235H. Approximately 4,600 units were distributed nationwide across all U.S. states and territories, as well as internationally to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Africa, Spain, and other countries.

The infusion sets pose a potential hazard of fluid leakage from the air vents on the inline filters. The source document does not specify what consumers or healthcare providers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Details from the source

Reason for recall: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Ta Quantity: 4,600 units Lot/code info: Product Code: 240100401, Lot number (UDI Number): 897525H (20887787009259, 10887787009252), 905915H (20887787009259, 10887787009252), 926235H (20887787009259, 10887787009252)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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