Reported May 8, 2019 · Terminated
EZ Derm Porcine Xenograft, labeled as the following
Molnlycke Health Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Molnlycke Health Care, Inc · 5550 Peachtree Pkwy Ste 500 · Norcross, GA · 30092-2555
Is this the product you have?
EZ Derm Porcine Xenograft, labeled as the following
9 of 9 products
| Model / number | Product as published |
|---|---|
131703-03 | EZ Derm 3x4 (8x10 cm) Non-Perforated |
131704-03 | EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated |
131705-03 | EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated |
131710-03 | EZ Derm 3 x 48 (8 x 122 cm) Perforated |
131711-03 | EZ Derm 3 x 24 (8 x 61 cm) Perforated |
131712-03 | EZ Derm 3 x 12 (8 x 30 cm) Perforated |
131713-03 | EZ Derm 3 x 4 (8 x 10 cm) Perforated |
131714-03 | EZ Derm 7 x 18 (17 x 46 cm) Perforated |
131715-03 | EZ Derm 2 x 2 (5 x 5 cm) Perforated. Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts. |
- Amount recalled
- 1,332 units
Where it was sold
Why it was recalled
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
This product could cause temporary or reversible health problems — stop using it.
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