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Terminated

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.

FDA Recall Z-1243-2019 · Posted None

Recalling FirmMolnlycke Health Care, Inc
Recall StatusTerminated
Product CodeKGN
Date Initiated2019-03-26
Date Terminated2021-06-02
Product Quantity1,332 units

Reason for Recall

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

Firm 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.

Root Cause

Equipment maintenance

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935189E-Z DERM BIOSYNTHETIC WOUND DRESSINGBrennen Medical, Inc. · 1994-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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