Class 2 Device Recall Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS

• Date Initiated by Firm: July 20, 2016
• Create Date: September 30, 2016
• Recall Status: Terminated on March 02, 2018
• Recall Number: Z-2917-2016
• Recall Event ID: 75019
• Product Classification: Non-surgical isolation gown - Product Code OEA
• Product: 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
• Code Information: All Lots with material number 5213PG and V5213PG
• Recalling Firm/ Manufacturer: Cardinal Health; 1430 S Waukegan Rd; Waukegan IL 60085-6726
• For Additional Information Contact: Michele Donatich; 847-887-6412
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: The firm sent an URGENT: PRODUCT RECALL dated 7/20/2016 describing the reason for the recall. The letter also provides instructions for the user on how to address this issue. Cardinal Health anticipates replacement inventory of 5213PG will be available by August 22, 2016 and V5213PG by August 29. Until that time, the recommended substitute product is 5210PG, which shares all the design characteristics of 5213PG (blue polyethylene film material, over-the-head donning/tear-away removal, half-back, thumb hook wrists) and comes in similar packaging (15 individually packed gowns per box, 5 boxes per case for a total of 75 gowns per case). The firm advises that the 5210PG is "Universal" size, which is smaller than 5213PG (XL size), so it may not work for all users. The firm is requesting all customers to take the following actions: 1. Immediately stop distributing affected product. 2. Return the enclosed acknowledgment form via fax to 847.689.9101, whether or not they have affected product, as Cardinal Health is required to confirm receipt of this notification. 3. Contact the Distributor Management Customer Service team at 800.635.6021 to arrange for credit and return of any affected product they may have. 4. Customers do not need to notify any customers to whom they may have distributed product affected by this recall. If they have any questions relating to this recall, please contact Cardinal Health Customer Advocacy at 800.292.9332.
• Quantity in Commerce: 4,062,511 eaches
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.