ICU Medical recalls PROXIMALE IV sets with NanoClave manifold due to potential leaks or separation between the luer and manifold. Affected units have specific lot numbers and expiration dates.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
ICU Medical is recalling certain IV administration sets that may leak or separate at the connection point, which could lead to improper fluid delivery. This recall affects medical devices used in healthcare settings.
The NanoClave manifold may develop leaks or separate from the female luer connector, potentially causing improper fluid flow or disconnection during use. This could lead to incorrect medication delivery or complications for patients.
Healthcare professionals using these IV sets in medical facilities are most at risk. Patients receiving treatment with the recalled sets could be affected if the connection fails.
Check for the product name 'PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold' with specific lot numbers: 3358780, 3365174, 3367857, 3497708, or 3508531. Expiration dates range from November 1, 2021, to August 1, 2022.
Verify the lot number and expiration date against the listed numbers and dates to confirm if your set is affected.
The recall is due to potential leaks or separation between the female luer and NanoClave manifold, which could cause improper fluid delivery.
Check for the specific lot numbers: 3358780, 3365174, 3367857, 3497708, or 3508531, with expiration dates from November 1, 2021, to August 1, 2022.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2805-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2805-2018 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.
