ICU Medical Inc: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAV

Is my product affected?

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787007439
• UPC 10887787007432

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

What happened

ICU Medical Inc. has recalled 51,250 units of Sapphire Microbore Infusion Sets with Inline Filters (Product Code 163830455) due to a potential for fluid leakage out of air vents on the inline filters. The affected product was distributed nationwide across all U.S. states and territories, as well as internationally to countries including Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, and Spain. The recalled units include specific lot numbers: 855665H, 865495H, 896195H, 3849197, and 4064964.

The recall record does not specify what actions affected consumers should take in response to 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: 51,250 units Lot/code info: Product Code: 163830455, Lot number (UDI Number): 855665H (20887787007439, 10887787007432), 865495H (20887787007439, 10887787007432), 896195H (20887787007439, 10887787007432), 3849197 (20887787007439, 10887787007432), 4064964 (20887787007439, 10887787007432)

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

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All FDA (Device enforcement) recalls