Angiodynamics recalls specific Smart Port CT-Implantable Port kits (CT96STSD-VI, CT96STSA-VI) due to potential sterility compromise. Affected lots include 5616651, 5647359, 5654135 and 5654129. Contact for remedy.
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Angiodynamics is recalling specific batches of Smart Port CT-Implantable Port kits that may have compromised sterility. This could lead to infections if the device is used without proper sterilization.
The recalled kits may have compromised sterility, meaning the device could become contaminated during use. This increases the risk of infection if the device is not properly sterilized before use.
Patients using the recalled Smart Port CT-Implantable Port kits for repeated vascular access are affected. Those with the specific lot numbers listed are most at risk.
Check for the product catalog numbers CT96STSD-VI or CT96STSA-VI. Affected lots include 5616651, 5647359, 5654135 and 5654129.
Look for the lot number on the device packaging or label to determine if it is affected.
No, only the specific product/lot of the kit identified in the recall is affected.
The risk is potential sterility compromise, which could lead to infection if the device is not properly sterilized.
Check the product catalog numbers CT96STSD-VI or CT96STSA-VI and the lot numbers listed: 5616651, 5647359, 5654135, and 5654129.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-1466-2021 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-1466-2021 from Angiodynamics. 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.
