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U.S. Department of Health and Human Services

Class 2 Device Recall BLUE BURN SHEET

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  Class 2 Device Recall BLUE BURN SHEET see related information
Date Initiated by Firm June 01, 2017
Create Date December 12, 2017
Recall Status1 Terminated 3 on July 19, 2018
Recall Number Z-0233-2018
Recall Event ID 77673
Product Classification Sheet, burn - Product Code FPY
Product BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01

Product Usage - May provide a sterile, barrier environment to protect patient from infection.
Code Information Lot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408, JT31408, JT33508, JT00609, JT04809, JT15209, JT18209, JT19209, JT22409, JT22709, JT23209, JT25309, JT25809, JT27509, JT30109, JT31309, JT32909, JT17510, JT23610, JT24010, JT24810, JT30810, JT35910, JT00811, JT05011, JT07911, JT11511, JT15911, JT17011, JT18211, JT21511, JT26311, JT28411, JT30711, JT00812, JT07312, JT11812, JT13612, JT17712, JT21812, JT25612, JT33012, JT36112, JT36212, JT09113, JT17513, JT24713, JT29813, JT33513, JT01614, JT04614, JT06814
Recalling Firm/
Manufacturer		 Dukal Corp.
2 Fleetwood Ct
Ronkonkoma NY 11779-6907
For Additional Information Contact Richard Lanzillotto
631-656-3800
Manufacturer Reason
for Recall		 Intact carton revealed presence of shredded burn sheets
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On May 30, 2017 Dukal sent an Urgent Product Recall notices and response forms to customers via UPS Overnight mail. On June 5, 2017 an amended recall notice was sent to customers to identify the correct the item number which is 7305. Customers were advised to do the following: 1. Email or fax the enclosed return card by June 30, 2017. 2. Immediately segregate your inventory of all Burn Sheet lots prefixed JT, Stop sales of such product and place in quarantine. 3. If you have further distributed this product, identify your customers, notify them of these lots being recalled and ask them to return the product for a full refund or replacement. 4. Product being recalled that is held in your inventory, as well as returns of that product from your customers, should be shipped to back to Dukal. Please contact Dukal service at 1-800-243-0741 for an RMA number. Upon receipt we will issue a full replacement or credit for product returned. All Product should be returned to the following Address: GEODIS 2385 Tremont Road Savannah, GA 31405 Tel. : +1 912 232 6125
Quantity in Commerce 12095 cases/12 Packs per case/1 sheet
Distribution Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada
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.
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