• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall DermaCol

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall DermaCol see related information
Date Initiated by Firm May 25, 2022
Date Posted September 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1796-2022
Recall Event ID 90731
510(K)Number K060804  
Product Classification Dressing, wound, drug - Product Code FRO
Product a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E.
b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen Dressing DermaCol/Ag 2 X 2 Inch Square Sterile Model Number: 00502E
Code Information GTIN: a. 01714196303447; 00714196391322; 00714196303448. b. 00714196391421; 01714196502222; 00714196502223
Recalling Firm/
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information Contact
804-553-2281
Manufacturer Reason
for Recall
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
FDA Determined
Cause 2
Environmental control
Action Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Quantity in Commerce a. 12 b. 60
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = COVALON TECHNOLOGIES LTD.
-
-