FDA recall Z-0266-2019

Custom Healthcare Systems, Inc. · Class II · device

Product

CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG

Reason for recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Distribution

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

Key facts

Status
Terminated
Initiation date
2018-08-13
Report date
2018-10-31
Termination date
2022-08-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0266-2019