FDA recall Z-0018-2019

Product

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Reason for recall

Potential for product sterility breach due to a compromised or pinched seal defect

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2018-10-10

Termination date

2020-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2019