Teleflex Medical recalls Pilling Aortic Punch 4.0mm Standard Tip (REF 353440) due to potential packaging compromise affecting sterility. Affected units sold with lot number 74B1500674.
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Teleflex Medical is recalling a specific type of aortic punch device because its packaging might be damaged, which could mean the device isn't sterile. This is serious for medical procedures where sterility is critical.
The device packaging may become damaged during shipping or storage, which could allow contamination. If the device isn't sterile, it could cause infections during medical procedures.
Healthcare professionals using this device for medical procedures are most at risk. Patients receiving the device could face infection if the packaging is compromised.
Check for the model 'Pilling Aortic Punch, 4.0 mm Standard Tip' with reference number 353440 and lot number 74B1500674 on the packaging.
Immediately stop using the recalled device as it may not be sterile, posing infection risks during medical procedures.
The device packaging may become compromised, which could mean the device isn't sterile. This could lead to infections during medical procedures.
Immediately stop using it as it may not be sterile. Contact Teleflex Medical for further instructions.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1269-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1269-2020 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.
