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Custom Healthcare Systems, Inc. recalls CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-
Recalled October 31, 2018 · FDA recall Z-0266-2019 · Custom Healthcare Systems
Hazard
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility · FDA Class II
Units
72832 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 (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
Manufacturer(s)
Custom Healthcare Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →