ICU Medical Inc: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0

Is my product affected?

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 c

• UPC 10887709100166
• UPC 20887709100163

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

What happened

ICU Medical Inc. is recalling approximately 6,400 units of Plum Microbore Infusion Sets with Inline Filters, specifically those labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber with CLAVE Secondary Port. The affected product codes are 140099291, with lot numbers 3981726 and 4065006. The infusion sets 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, the Philippines, Poland, Saudi Arabia, South Africa, and Spain.

The recall was issued due to a potential for fluid leakage out of the air vents on the inline filters of these infusion sets. The source document does not specify a remedy or any required actions for consumers who have obtained 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: 6,400 units Lot/code info: Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163)

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls