ICU Medical Inc: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 I

Is my product affected?

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

• UPC 20887787007361
• UPC 10887787007364

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

What happened

ICU Medical Inc. is recalling approximately 155,150 units of Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter. The infusion sets have a potential hazard of fluid leaking 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 recalled products have specific lot numbers and UDI numbers associated with Product Code 163630455. Consumers can identify affected units by checking for lot numbers 876175H, 885385H, 896995H, 908235H, 925755H, or 3843264. The source document does not specify what remedy or actions affected consumers should take.

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: 155,150 units Lot/code info: Product Code: 163630455, Lot number (UDI Number): 876175H (20887787007361, 10887787007364), 885385H (20887787007361, 10887787007364), 896995H (20887787007361, 10887787007364), 908235H (20887787007361, 10887787007364), 925755H (20887787007361, 10887787007364), 3843264 (20887787007361, 10887787007364)

Source

Official record: FDA (Device enforcement) ↗

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

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