ICU Medical Inc: Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Ora

Is my product affected?

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouche

• UPC 20887787009020
• UPC 10887787009023

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

What happened

ICU Medical Inc. is recalling Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convertible Pin, 104 Inch with Ora due to a potential for fluid leakage out of air vents on the inline filters. Approximately 170,735 units have been distributed nationwide across all U.S. states and territories, as well as internationally to multiple countries including Canada, France, Germany, and others.

The recalled infusion sets are identified by Product Code 118790412 and several lot numbers including 855505H, 865135H, 918695H, 928085H, 937325H, and others with corresponding UDI numbers. The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 170,735 units Lot/code info: Product Code: 118790412, Lot number (UDI Number): 855505H (20887787009020, 10887787009023), 865135H (20887787009020, 10887787009023), 918695H (20887787009020, 10887787009023), 928085H (20887787009020, 10887787009023), 937325H (20887787009020, 10887787009023), 3864774 (20887787009020, 10887787009023), 3935434 (20887787009020, 10887787009023), 4011065 (20887787009020, 10887787009023), 4088425 (20887787009020, 10887787009023)

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case2019-07-29
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• 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 case2019-07-29

All FDA (Device enforcement) recalls