ICU Medical recalls Plum Microbore Infusion Sets with Inline Filters due to potential fluid leakage from air vents. Affected units have specific model codes and were not sold in the U.S. Learn how to check and what to do.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
ICU Medical is recalling Plum Microbore Infusion Sets with Inline Filters labeled as Primary because they may leak fluid from air vents. This could cause improper medication delivery and potential harm to patients using the pumps.
Fluid may leak from the air vents on the inline filters, which could lead to improper medication delivery. This might cause incorrect dosing or contamination of the medication, potentially harming patients.
Healthcare professionals using ICU Medical's Plum Microbore Infusion Sets with Inline Filters labeled as Primary are most at risk. Patients receiving IV treatments with these sets could be affected if the leakage occurs.
Check for Plum Microbore Infusion Sets with Inline Filters labeled as Primary. The product code is 140099291, and lot numbers include 3981726 (10887709100166, 20887709100163) or 4065006 (10887709100166, 20887709100163). These sets were not distributed in the U.S.
Verify if your set has the product code 140099291 and lot numbers listed above. These sets were not sold in the U.S.
No, these sets were not distributed in the U.S. according to the recall record.
The recalled sets are Plum Microbore Infusion Sets with Inline Filters labeled as Primary, specifically the 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 cm / 15 mL.
Check for the product code 140099291 and lot numbers 3981726 or 4065006 (10887709100166, 20887709100163). These sets were not distributed in the U.S.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0138-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0138-2020 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.