Home / Recalls / Medical Devices
Custom Healthcare Systems, Inc. recalls CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Recalled October 31, 2018 · FDA recall Z-0246-2019 · Custom Healthcare Systems
Hazard
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility · FDA Class II
Units
160 units
Sold at
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Description
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Product
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Manufacturer(s)
Custom Healthcare Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →