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

Z-0266-2019

August 13, 2018

Class II

Product summary

Firm: Custom Healthcare Systems, Inc.
Event: Event 81179
Status: Terminated
Classification: Class II
Quantity: 72832 units
Official record key: device-enforcement:Z-0266-2019

Official wording

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

Code information: (1)1231-150L GOWN, RAGLAN, LG, NONREINF Lot Numbers: W72318,W72118 (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF Lot Number: W72318 (3) 1231-140XL GOWN, SPECIALTY XL, XLONG Lot Number: W71818 Exp. Date: 7/1/2021

Distribution pattern: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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