Spiros medical IV sets with a molding defect may leak fluid, causing delays, contamination, or exposure risks. Affected units include specific lengths and model numbers.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Spiros medical IV administration sets with a molding defect can leak fluid, potentially causing delays in treatment, contamination, or exposure to hazardous medications. This recall affects specific product models and sizes sold in the U.S.
A molding defect in the male luer connectors can cause fluid leaks. This may lead to delays in medication delivery, contamination of the fluid path, exposure to hazardous medications, blood loss, or air entering the fluid line.
Healthcare professionals and patients using Spiros IV sets with the described defect. Those most at risk are individuals receiving intravenous treatments with these specific models.
Check for Spiros IV sets with model numbers like CH3330-C, CH3353, CH3367, CH3379, CH3381, CH3386, CH3401, CH3453, CH3485, CH3517, CH3523, CH3533, CH3538, CH3556, CH3603, B4194, Z7093, or Z7182. These were sold with specific lot numbers listed in the recall.
Identify the model number and lot number on your Spiros IV set to confirm if it is affected by this recall.
The recall includes Spiros IV sets with model numbers such as CH3330-C, CH3353, CH3367, CH3379, CH3381, CH3386, CH3401, CH3453, CH3485, CH3517, CH3523, CH3533, CH3538, CH3556, CH3603, B4194, Z7093, and Z7182.
Look for the model numbers listed in the recall and check the lot numbers provided, which include specific sequences like 4764635, 4887770, and others.
The recall does not specify a remedy, so you should check the product details to confirm if it is affected and contact the manufacturer for further guidance.
We’ve drafted a message you can send Spiros to request your refund or repair — edit it as you like.
Subject: Recall Z-0699-2021 — Spiros Spiros Hello, I own a Spiros that is covered by recall Z-0699-2021 from Spiros. 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.
