Cardinal Health told its customers Jan. 11 and Jan. 15 to not use its level three surgical gowns due to the manufacturer not being able to guarantee the products are sterile, according to a release from the FDA.
The FDA acknowledged the possibility that the quality issue could cause hospitals and surgery centers to cancel elective surgeries. The FDA said it is working with Cardinal to determine which specific products are affected by the issue, and will issue a recall soon.
According to the Columbus Dispatch and Allegheny TribLive, nonemergency and elective procedures were rescheduled at Allegheny surgery centers in Pennsylvania.
The FDA said it is working with Cardinal to determine which specific products are affected by the issue, and will issue a recall soon.