Recall Z-2917-2016 ยท OEA Non-Surgical Gown
Cardinal Health
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 barrie
| Date | Jul 20, 2016 |
| Status | Terminated |
| Reason | 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 c |
| Root 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 p |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.