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 Microbore, 122 Inch. 1 unit per

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 Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787007316
• UPC 10887787007319

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

What happened

ICU Medical Inc. has recalled approximately 73,710 units of Sapphire Microbore Infusion Sets with Inline Filters (Product Code 163350455) that were distributed nationwide across the United States and internationally to multiple countries including Canada, Chile, France, Germany, and others. The recalled infusion sets are identified by specific lot numbers including 855935H, 855965H, 876145H, 885395H, 896135H, 936605H, 3843263, and 3864786.

The recall was initiated because these infusion sets have the potential for fluid leakage out of air vents on the inline filters. The source document does not specify a remedy or instructions for affected consumers.

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: 73,710 units Lot/code info: Product Code: 163350455, Lot number (UDI Number): 855935H (20887787007316, 10887787007319), 855965H (20887787007316, 10887787007319), 876145H (20887787007316, 10887787007319), 885395H (20887787007316, 10887787007319), 896135H (20887787007316, 10887787007319), 936605H (20887787007316, 10887787007319), 3843263 (20887787007316, 10887787007319), 3864786 (20887787007316, 10887787007319)

Source

Official record: FDA (Device enforcement) ↗

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

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