ICU Medical recalls Sapphire Microbore Infusion Sets with inline filters due to potential fluid leakage from air vents. Affected units sold outside the U.S. with specific product codes and lot numbers.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid can leak from air vents. This could cause medication to leak out of the patient's IV line, potentially leading to incorrect dosing or infection risks.
The inline filters on these infusion sets have air vents that can leak fluid. This leakage might cause medication to escape the IV line, leading to incorrect dosing or potential infection risks for patients.
Healthcare professionals using these infusion sets in medical facilities. Patients receiving IV treatments with the recalled sets are at risk of medication leakage.
Check for product labels stating 'SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL'. The product code is 163359255 with specific lot numbers listed in the recall notice. These units were not distributed in the U.S.
Look for the product label indicating 'SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL' on the infusion set.
No, these units were not distributed in the U.S. according to the recall notice.
The product code is 163359255 with specific lot numbers: 855875H, 866155H, 876265H, 885645H, 887125H, 905965H, 945565H.
Check the product label for 'SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL' and verify the product code and lot numbers listed in the recall notice.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0141-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0141-2020 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.
