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BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical...

FDA Device Recall #Z-2917-2016 — Class II — July 20, 2016

Recall Summary

Recall Number Z-2917-2016
Classification Class II — Moderate risk
Date Initiated July 20, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health
Location Waukegan, IL
Product Type Devices
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.

Lot / Code Information

All Lots with material number 5213PG and V5213PG

Other Recalls from Cardinal Health

Recall # Classification Product Date
Z-0360-2023 Class II Dover Closed Urethral Tray with Vinyl Catheter ... Nov 1, 2022
Z-0359-2023 Class II Dover Closed Urethral Tray with Vinyl Catheter ... Nov 1, 2022
Z-0357-2023 Class II Dover Closed Urethral Tray with Hydrogel Coated... Nov 1, 2022
Z-0356-2023 Class II Dover Closed Urethral Tray with Vinyl Catheter ... Nov 1, 2022
Z-0358-2023 Class II Dover Closed Urethral Tray with Hydrogel Coated... Nov 1, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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