Revmedx Inc: Medical Device Recall in 2015 - (Recall #: Z-2762-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

Product Classification:

Class II

Date Initiated: August 12, 2015

Date Posted: September 23, 2015

Recall Number: Z-2762-2015

Event ID: 72019

Reason for Recall:

The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.

Status: Terminated

Product Quantity: 5004 units

Code Information:

Lot ESO54391, Expiration Date 9/25/2020; Lot ESO54725, Expiration Date 3/18/2020; Lot ESO54726, Expiration Date 3/30/2020; Lot ESO54741, Expiration Date 4/6/2020; Lot ESO54742, Expiration Date 4/13/2020; Lot ESO54743, Expiration Date 4/16/2020; Lot ESO54744, Expiration Date 4/23/2020;

Distribution Pattern:

US Distribution to the states of : Arizona, Idaho, North Carolina, Tennessee and Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated