Cardinal Health: Medical Device Recall in 2016 - (Recall #: Z-2917-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific. An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material

Product Classification:

Class II

Date Initiated: July 20, 2016

Date Posted: October 12, 2016

Recall Number: Z-2917-2016

Event ID: 75019

Reason for Recall:

Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.

Status: Terminated

Product Quantity: 4,062,511 eaches

Code Information:

All Lots with material number 5213PG and V5213PG

Distribution Pattern:

Nationwide to U.S. consignees located in the following states:AL ,AR ,AZ ,CA ,CT ,FL ,GA ,IL ,IN ,KY ,LA ,MA ,MD ,MI ,MO ,NC ,NJ ,NM ,NV ,NY ,OH ,PA ,SC ,TX ,UT ,VA ,WA and WV.

Voluntary or Mandated:

Voluntary: Firm initiated