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, Microbore, CLAVE Y-Site, 118 In

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, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787007354
• UPC 10887787007357

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

What happened

ICU Medical Inc. is recalling approximately 45,900 units of Sapphire Microbore Infusion Sets with Inline Filters, specifically those labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 In. The infusion sets have a potential hazard of fluid leakage from air vents on the inline filters. The affected products 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 Arabia, South Africa, Spain, and other locations.

The recall involves four specific lot numbers and product codes: Product Code 163620455 with UDI Numbers 855645H, 885415H, 896625H, and lot number 4008547. Affected consumers should contact ICU Medical Inc. for further instructions, as the recall record does not specify a remedy or corrective action.

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: 45,900 units Lot/code info: Product Code: 163620455, Lot number (UDI Number): 855645H (20887787007354, 10887787007357), 885415H (20887787007354, 10887787007357), 896625H (20887787007354, 10887787007357), 4008547 (10887787007357, 20887787007354)

Source

Official record: FDA (Device enforcement) ↗

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

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