| Class 2 Device Recall BLUE BURN SHEET | |
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
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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 |
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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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