Z-1243-2019Class II

EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number...

Name: Z-1243-2019 EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number...
Creator: Molnlycke Health Care, Inc
Published: 2019-03-26
License: https://open.fda.gov/license/

Molnlycke Health Care / initiated 2019-03-26 / Terminated / root cause: manufacturing process

FDA source

Molnlycke Health Care, Inc began a recall of 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)... on 2019-03-26. FDA classified it as Class II and gives the reason as "Intermittent heat seal failures on the outer pouch of some EZ Derm products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1243-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-26
Posted: 2019-04-30
Terminated: 2021-06-02
Recalling firm: Molnlycke Health Care
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 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 code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Intermittent heat seal failures on the outer pouch of some EZ Derm products.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Molnylcke notified consignees on about 03/26/2019 via "URGENT FIELD SAFETY NOTICE" letter. Consignees were instructed to review current inventory for affected devices, separate and discard affected devices, complete and return the Confirmation Form, and replacement product will be provided or credit issue after receipt of the completed Confirmation Form. If product was further distributed, consignees were instructed to forward a copy of the Field Safety Notice with the Confirmation Form and request that they return the Confirmation Form to them and send their reconciliation results to Molnlycke. Questions or comments can be directed to Molnlycke Customer Service at 1-800-843-8497 or your Account Manager/Sales Representative.
Quantity in commerce: 1,332 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1243-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1243-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-04-30

Product code KGN

K935189UnclassifiedE-Z Derm Biosynthetic Wound DressingBrennen Medical, Inc. / cleared 1994-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)