ICU Medical recalls 7" Smallbore Ext Set w/MicroClave T-Connector due to incorrect spin collar. This device is used for sterile fluid administration in medical settings. Affected units have specific lot numbers.
The infusion sets were manufactured with an incorrect spin collar.
ICU Medical is recalling 7" Smallbore Ext Set w/MicroClave T-Connector sets because they were manufactured with an incorrect spin collar. This could cause improper function during medical use, potentially leading to safety issues for patients receiving intravenous treatments.
The spin collar was manufactured incorrectly, which could lead to improper function of the device during medical use. This might cause issues with fluid administration, potentially affecting patient safety.
Healthcare professionals using the 7" Smallbore Ext Set w/MicroClave T-Connector for intravenous fluid administration are most at risk. Patients receiving treatments through this device may be affected if the incorrect spin collar causes improper function.
Check for the product name '7" Smallbore Ext Set w/MicroClave T-Connector' with lot numbers 3482848, 3511823, 3516092, or 3545075. The device is a single-use sterile medical product used for intravenous fluid administration.
Look for lot numbers 3482848, 3511823, 3516092, or 3545075 on the device packaging or label.
The recall record does not specify the correct spin collar or replacement details.
Check the lot number on your device packaging or label. Affected units have lot numbers 3482848, 3511823, 3516092, or 3545075.
The recall record does not mention any remedy or fix for the incorrect spin collar.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1345-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1345-2018 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.
