Teleflex Medical recalls disposable aortic punch devices (2.8mm to 6.0mm) due to potential packaging compromise affecting sterility. Affected units have specific model numbers and lot numbers listed in the recall.
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Teleflex Medical is recalling disposable aortic punch devices in sizes 2.8mm to 6.0mm because the packaging might be compromised, which could mean the device isn't sterile. This risk could lead to infection if the device is used without proper sterility.
The packaging might be compromised, which means the device might not be sterile when it's supposed to be. This could lead to infection if the device is used without proper sterility.
Healthcare professionals and medical facilities that use these devices are most at risk. Patients using the devices could be affected if the packaging is compromised and the device isn't sterile.
Check the device size (2.8mm to 6.0mm) and the reference code (DP-28K to DP-60K or MDP-28K to MDP-60K). Look for the specific lot numbers listed in the recall notice.
Identify the device size and reference code (e.g., 2.8mm, REF DP-28K) to confirm if it's affected.
Reach out to Teleflex Medical for confirmation and instructions on what to do with the affected devices.
The recall states there's a potential for packaging to be compromised, which could affect sterility. Affected units should not be used until the manufacturer confirms they are safe.
Check the device size (2.8mm to 6.0mm) and reference code (DP-28K to DP-60K or MDP-28K to MDP-60K). Compare with the specific lot numbers listed in the recall notice.
Contact Teleflex Medical directly to confirm if your device is affected and follow their instructions for safe disposal or replacement.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1270-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1270-2020 from Teleflex 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.