ICU Medical Inc: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123

Is my product affected?

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787007446
• UPC 10887787007449

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

What happened

ICU Medical Inc. is recalling 19,350 units of Sapphire Microbore Infusion Sets with Inline Filters (Product Code 163840455) that were distributed nationwide and internationally. These infusion sets, which are used to deliver fluids intravenously, have a potential safety issue: fluid may leak out of the air vents on the inline filters.

The recalled product includes specific lot numbers: 855995H, 865505H, and 876185H. The source document does not specify a remedy or recommended action for consumers who have this product.

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: 19,350 units Lot/code info: Product Code: 163840455, Lot number (UDI Number): 855995H (20887787007446, 10887787007449), 865505H (20887787007446, 10887787007449), 876185H (20887787007446, 10887787007449)

Source

Official record: FDA (Device enforcement) ↗

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

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• Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case2019-07-29
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All FDA (Device enforcement) recalls