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U.S. Department of Health and Human Services

Class 2 Device Recall EZ Derm Porcine Xenograft

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  Class 2 Device Recall EZ Derm Porcine Xenograft see related information
Date Initiated by Firm March 26, 2019
Create Date April 30, 2019
Recall Status1 Terminated 3 on June 02, 2021
Recall Number Z-1243-2019
Recall Event ID 82522
510(K)Number K935189  
Product Classification Dressing, wound, collagen - Product Code KGN
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.
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
Recalling Firm/
Manufacturer		 Molnlycke Health Care, Inc
5550 Peachtree Pkwy Ste 500
Norcross GA 30092-2555
For Additional Information Contact
800-843-8497
Manufacturer Reason
for Recall		 Intermittent heat seal failures on the outer pouch of some EZ Derm products.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGN and Original Applicant = BRENNEN MEDICAL, INC.
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