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

Products covered by this recall
Model / numberProduct as published
131703-03EZ Derm 3x4 (8x10 cm) Non-Perforated
131704-03EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated
131705-03EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated
131710-03EZ Derm 3 x 48 (8 x 122 cm) Perforated
131711-03EZ Derm 3 x 24 (8 x 61 cm) Perforated
131712-03EZ Derm 3 x 12 (8 x 30 cm) Perforated
131713-03EZ Derm 3 x 4 (8 x 10 cm) Perforated
131714-03EZ Derm 7 x 18 (17 x 46 cm) Perforated
131715-03EZ 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 2, 2021 · Data as of Sep 19, 6:57 PM UTC

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