Oscor recalls AngioDynamics SafeSheath ULTRALITE 10:10F model VI10 due to potential open seal on sterile product. This could compromise sterility during medical procedures.
Potential for open seal on sterile product
Oscor is recalling AngioDynamics SafeSheath ULTRALITE 10F model VI10 because it may have an open seal on the sterile product. This could lead to contamination during medical procedures if the device is used without proper sterility.
The device is designed to be sterile for medical procedures. If the seal is open, it could allow contamination of the product, potentially leading to infections during procedures.
Healthcare professionals who use this device for medical procedures are most at risk. Patients using this device could be affected if the seal is compromised.
Check for the model number VI10 on the device. The product was sold with lot number DP-11759 and is intended for medical use.
Inspect the device for any signs of an open seal. If the seal appears compromised, do not use the device.
The device may have an open seal, which could compromise sterility. Do not use if the seal appears compromised.
Check the device for an open seal. If the seal appears compromised, do not use it. Contact the manufacturer for further guidance.
Look for the model number VI10 and lot number DP-11759 on the device.
We’ve drafted a message you can send Oscor to request your refund or repair — edit it as you like.
Subject: Recall Z-1329-2021 — Oscor Oscor Hello, I own a Oscor that is covered by recall Z-1329-2021 from Oscor. 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.
