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, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787009266
• UPC 10887787009269

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 labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore due to a potential for fluid leakage out of air vents on the inline filters. The affected product has been 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 Arabia, South Africa, Spain, and other countries. The recall involves 50 units with Product Code 240130401 and specific lot numbers including UDI Numbers 885585H and 925855H.

The source document does not specify a remedy or instructions for what affected consumers 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: 50 units Lot/code info: Product Code: 240130401, Lot number (UDI Number): 885585H (20887787009266, 10887787009269), 925855H (20887787009266, 10887787009269),

Source

Official record: FDA (Device enforcement) ↗

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

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