Molnlycke recalls EZ Derm Porcine Xenograft products with intermittent heat seal failures that could lead to pouch separation. Affected items include specific sizes and part numbers.
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
Molnlycke is recalling certain EZ Derm Porcine Xenograft products due to a risk of heat seal failures on the outer pouch. This could cause the product to separate, potentially leading to skin injury or infection if used improperly.
The outer pouch of some EZ Derm products can develop intermittent heat seal failures, causing the pouch to separate from the product. This separation could lead to the product no longer providing proper skin coverage, increasing the risk of infection or skin injury.
People who use EZ Derm for skin injuries, burns, or ulcers are most at risk. Patients using the recalled products for temporary skin coverage or grafts should check if they have the affected items.
Check the product label for the specific size and part number listed. Affected items include EZ Derm 3x4 (8x10 cm) Non-Perforated (Part Number 131703-03) and other sizes with the listed part numbers and lot numbers.
Look for the part number and lot number on the product label to determine if it is affected.
Affected products include EZ Derm 3x4 (8x10 cm) Non-Perforated (Part Number 131703-03), EZ Derm 7x18 (17x46 cm) Non-Perforated (Part Number 131704-03), and other sizes with specific part numbers and lot numbers listed in the recall.
Check the product label for the part number and lot number. Affected items have specific part numbers (e.g., 131703-03) and lot numbers listed in the recall notice.
The recall does not specify a remedy, so contact Molnlycke Health Care directly for guidance on next steps.
We’ve drafted a message you can send Molnlycke to request your refund or repair — edit it as you like.
Subject: Recall Z-1243-2019 — Molnlycke Molnlycke Hello, I own a Molnlycke that is covered by recall Z-1243-2019 from Molnlycke. 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.
