Molnlycke Health Care, Inc: Medical Device Recall in 2019 - (Recall #: Z-1243-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 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.

Product Classification:

Class II

Date Initiated: March 26, 2019

Date Posted: May 8, 2019

Recall Number: Z-1243-2019

Event ID: 82522

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,332 units

Code Information:

a. Part Number: 131703-03, Lot Numbers: 18418740, 18489748, 18489749, 18489750, 18497584, 18515343, 18515344, 19010755, 19011801, 19024014, 19024015, 19024017, 19027570, 19034016, 19041030, 19054457; b. Part Number: 131704-03, Lot Numbers: 18489747, 19041029; c. Part Number: 131705-03, Lot Numbers: 18409561, 18411794, 18421375, 18421378, 18448600, 18457912, 18458926, 18460179, 18489746, 18497582, 18497583, 18505338, 18505339, 18505340, 19033438, 19033439; d. Part Number: 131710-03, Lot Numbers: 18409559, 18411793, 18421334, 18421377, 18435885, 18448598, 18453214, 18453297, 18453300, 18453303, 18505328, 18505329, 18505330; e. Part Number: 131711-03, Lot Number 18409562; f. Part Number: 131712-03, Lot Numbers: 18409557, 18411791, 18418739, 18421332, 18429844, 18435028, 18435029, 18448582, 18448596, 18458925, 18460132, 18460145, 18460174, 18460175, 18470176, 18489702, 18489703, 18489704, 18489745, 18497579, 18497580, 18497581, 18505332, 18505333, 18505334, 18515336, 18515337, 19024010, 19024011, 19024013, 19033435, 19034012; g. Part Number: 131713-03, Lot Numbers: 18411792, 18421333, 18421376, 18429855, 18435030, 18435031, 18435032, 18448584, 18448597, 18448599, 18453295, 18453298, 18453301, 18460133, 18460146, 18460177, 18470178; h. Part Number: 131714-03, Lot Numbers: 18409555, 18411790, 18418738, 18421331, 18435025, 18435026, 18448583, 18448595, 18460130, 18460134, 18460171, 18460172, 18470173, 18489699, 18489700, 18489701, 18497576, 18497577, 18497578, 18515341, 18515342, 19010584, 19024006, 19024007, 19024009, 19033234, 19033441, 19034008, 19041077, 19041080, 19054456; i. Part Number: 131715-03, Lot Numbers: 18435886, 18453296, 18453299, 19041079, 19041081

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated