Z-2917-2016 Class II Terminated
FDA device recall Z-2917-2016 was initiated by Cardinal Health on Jul 20, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2018). Affected quantity: 4,062,511 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2016
- Initiation Date
- Jul 20, 2016
- Termination Date
- Mar 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,062,511 eaches
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
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.
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.
Code Information
All Lots with material number 5213PG and V5213PG
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2917-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026