Deroyal Industries recalls Teleflex Pilling Aortic Punch 4.0mm devices due to potential sterile packaging compromise. This surgical device, used in cardiac procedures, may be unsafe if packaging is damaged.
The sterile packaging has the potential to be compromised.
Deroyal Industries is recalling Teleflex Pilling Aortic Punch 4.0mm surgical devices because their sterile packaging might be compromised. This could lead to infection or contamination during cardiac surgery if the device is used without proper sterility.
The sterile packaging could be damaged, leading to contamination of the device. This might cause infection or improper sterility during critical cardiac surgery procedures.
Cardiovascular surgeons and medical facilities that use this device for cardiac surgery procedures. Patients undergoing surgery with this device are at risk if the packaging is compromised.
Check for the catalog number DP40K on the device packaging. Lot numbers 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, or 74D1700564 are included in this recall.
Inspect the device packaging for any signs of damage or compromise.
The recall states the sterile packaging has potential to be compromised, so it may not be safe for use without proper sterility checks.
The recall does not specify a remedy, so check the packaging for damage and contact Deroyal Industries for guidance.
Look for catalog number DP40K and lot numbers 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, or 74D1700564.
We’ve drafted a message you can send Deroyal Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-1483-2020 — Deroyal Industries Deroyal Industries Hello, I own a Deroyal Industries that is covered by recall Z-1483-2020 from Deroyal Industries. 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.
