FDA recall Z-0575-2023

Product

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09

Reason for recall

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Distribution

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Key facts

Status

Ongoing

Initiation date

2022-11-03

Report date

2022-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2023