Recall Z-1243-2019 ยท KGN Wound Dressing With Animal-Derived Material(S)
Molnlycke Health Care, Inc
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
| Date | Mar 26, 2019 |
| Status | Terminated |
| Reason | Intermittent heat seal failures on the outer pouch of some EZ Derm products. |
| 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 Moln |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING Brennen Medical, Inc., Jul 11, 1994 |