# FDA recall Z-1243-2019

> **Molnlycke Health Care, Inc** · Class II · device recall initiated 2019-03-26.

## Product

EZ Derm Porcine Xenograft, labeled as the following:      a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03;      b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03;      c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03;      d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03;      e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03;      f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03;      g.  EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03;      h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03;      i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03    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 Der

## Reason for recall

Intermittent heat seal failures on the outer pouch of some EZ Derm products.

## Distribution

Worldwide Distribution - US Nationwide distribution to AL, AZ, CA, CO, DC, FL, GA, IA, IL, KS, LA, MA, MD, MN, MO, NC, NE, NJ, OK, PA, RI, TN, TX, VA, WA, WI.      International distribution to Chile, Jamaica.

## Key facts

- **Recall number:** Z-1243-2019
- **Recalling firm:** Molnlycke Health Care, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-26
- **Report date:** 2019-05-08
- **Termination date:** 2021-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norcross, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2019

## Citation

> AI Analytics. FDA recall Z-1243-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1243-2019. Source: US FDA. Licensed CC0.

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