Cardinal Health on Jan. 15 announced a voluntary recall of 9.1 million surgical gowns and PreSource procedural packs containing gowns that were produced at a contract manufacturing facility that did not meet Food and Drug Administration (FDA) quality standards.
Surgical gowns are grouped into four levels based on their liquid barrier performance. Compromised sterility could increase risk of surgical site infections. This recall includes level 3 gowns, which provide moderate risk protection and are used in procedures such as open heart surgery and knee replacements. Affected gowns were produced between Sept. 1, 2018, and Jan. 10, 2020, and about 1.4 million gowns in the affected lots were not distributed.
After discovering contract manufacturers did not maintain proper environmental conditions, Cardinal Health started an investigation, quarantined the gowns, and halted distribution. The company created a webpage with information about the recall, including a list of affected lots, and is working with FDA to mitigate ensuing gown shortages.
Affected providers and distributors should quarantine the gowns, notify affected customers, and contact Cardinal Health Customer Service to arrange the return and replacement of the gowns. Cardinal Health asks health care providers and distributors, whether or not they were affected, to complete an acknowledgment form and return it via email at CardinalSurgicalGownRecall@cardinalhealth.com or fax at 614.495.5651.
FDA advises providers to report adverse reactions or quality problems associated with the affected products to the agency’s MedWatch Safety Information and Adverse Event Reporting Program. Health care providers should report gown shortages to FDA at firstname.lastname@example.org.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.