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FDA Device recall Z-0233-2018

BLUE BURN SHEET, STERILE, 60" x 96"

On 2017-12-20 the FDA classified a Class II recall of BLUE BURN SHEET, STERILE, 60" x 96" by Dukal, citing intact carton revealed presence of shredded burn sheets.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0233-2018
ClassificationClass II
Statusterminated
Initiated2017-06-01
Published2017-12-20
Last updated2026-09-13 11:54 UTC
CompanyDukal
DistributionUS

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.

Reason

Intact carton revealed presence of shredded burn sheets

Identifiers

code_info
Lot Numbers: JT13607, JT17507, JT35207, JT09008, JT11308, JT15408, JT18408, JT18708, JT23408, JT24508, JT26408, JT28408…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0233-2018%22

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