Zavation recalls 10G Direct Single Access catheters used in spinal procedures due to potential inadequate sterilization. Affected lots: 20061432. Consumers should contact manufacturer for details.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10G Direct Single Access catheters used in spinal procedures because some may not have been properly sterilized. This could lead to infections if used in medical procedures.
The catheters may not have been adequately sterilized, which could lead to infections during medical procedures. This is a risk for patients undergoing spinal or orthopedic surgeries.
Healthcare professionals using these catheters in spinal or orthopedic procedures. Patients undergoing such surgeries are at risk if the catheters are not properly sterilized.
Check for the lot number 20061432 on the catheter packaging. These catheters are used in spinal and orthopedic procedures and were distributed by Zavation.
Reach out to Zavation directly for specific instructions on how to handle the recalled product.
The recall indicates potential inadequate sterilization, so they may not be safe for use in medical procedures.
Contact Zavation directly for specific instructions on handling the recalled product.
The recall is due to potential infection risk from inadequate sterilization, not direct injury from the catheters themselves.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1727-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1727-2021 from Zavation. 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.
