WASHINGTON, D.C. — Cardinal Health announced that 9.1 million surgical gowns must be recalled due to concerns over whether the gowns are sterile or not. Cardinal Health said that a contractor who makes the gowns manufactured them in locations that were not previously approved by Cardinal Health. Cardinal Health also expressed concerns over whether these locations maintain appropriately sanitary conditions, according to medtech.phamaintelligence.informa.com. Cardinal Health designed the gowns for use in numerous surgical scenarios from open-heart surgery to joint replacement. Because of the recall, Cardinal Health must find a way to replace the recalled surgical gowns. Cardinal Health wanted its customers to stop using the gowns immediately because of the potential that the material is unsterile.
Cardinal Health sent a notice to its customers, warning them that the company cannot guarantee that its fabric-reinforced, non-reinforced, and Royal Silk non-reinforced made between September 1, 2018, and January 10, 2020, are sterile. Any downs manufactured before September 1, 2018, are safe to use, according to the company.
Cardinal Health reported to its customers and the FDA that its Level 3 surgical gowns should not be used any longer. The rating of a surgical gown is based on the level of protection the gown would provide. Thus, a Level 3 gown provides mid-level protection. Cardinal Health indicated a willingness to ship its Level 4 gowns to fill the void left by the instant recall campaign.
Cardinal Health broke down the distribution of the recalled gowns. Cardinal Health said that 7.7 million gowns were distributed among 2,807 medical facilities. The remaining 1.4 million gowns had not been distributed by the time Cardinal Health announced the recall.
Cardinal Health reportedly ended its contractual relationship with the gown manufacturer immediately upon learning about the unsanitary conditions in which the company made the gowns.
Cardinal Health has not received any injury reports or adverse medical events from unsanitary surgical gowns.
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