Surgical Cardinal Health dressing gowns

2020: Withdrawal more than 9 million surgical dressing gowns

At the end of January, 2020 because of problems with sterility of Cardinal Health withdrew more than 9 million surgical dressing gowns used during many surgical procedures including at open heart operations or prosthetics of a knee joint. Cardinal Health laid blame on the enterprise contractor which made dressing gowns on "unconfirmed platforms in which proper conditions of sterility were not supported".

The compromised dressing gowns came to the market during the period from September 1, 2018 to January 10, 2020. The Cardinal Health company emphasized that the dressing gowns made till 2018 are not subject to a response. From 9.1 million dressing gowns included in this response, 7.7 million units were distributed on 2807 hospitals. 1.4 million more dressing gowns came to the market, were not sold, Cardinal Health reports.

Because of problems with sterility of Cardinal Health withdrew more than 9 million surgical dressing gowns used during many surgical procedures including at open heart operations or prosthetics of a knee joint

Unsterile dressing gowns were also included in PreSource sets, however these sets are not subject to a response yet. The company claims that it will take necessary measures later, but recommends to clients not to use yet received surgical sets from which dressing gowns, most likely, do not meet sterility standards.

Dressing gowns 3 levels, i.e. surgical dressing gowns with the moderate level of protection against bacterial threats are subject to a response generally. To eliminate the potential shortage of dressing gowns 3 level, Cardinal Health increased production of "similar products" and provided to hospitals dressing gowns 4 levels that "overcome a temporary failure in deliveries of necessary means".

Cardinal Health lays blame on the contractor who did not respect the regulatory rules and made surgical dressing gowns on unsterile platforms. The Cardinal Health company reported that it broke off the contract with this producer.^[1]

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