FDA recall Z-0233-2018

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 for recall

Intact carton revealed presence of shredded burn sheets

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

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-12-20

Termination date

2018-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ronkonkoma, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2018