Z-0233-2018Class II

BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier...

Name: Z-0233-2018 BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier...
Creator: Dukal Corp.
Published: 2017-06-01
License: https://open.fda.gov/license/

Dukal LLC / initiated 2017-06-01 / Terminated / root cause: manufacturing process

FDA source

Dukal Corp. began a recall of 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 on 2017-06-01. FDA classified it as Class II and gives the reason as "Intact carton revealed presence of shredded burn sheets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0233-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-12-12
Terminated: 2018-07-19
Recalling firm: Dukal LLC
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.
Product code: FPY Sheet, Burn
Reason for recall: Intact carton revealed presence of shredded burn sheets
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0233-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0233-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-12

Product code FPY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)