Custom Healthcare Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0256-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: October 31, 2018

Recall Number: Z-0256-2019

Event ID: 81179

Reason for Recall:

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

Status: Terminated

Product Quantity: 50 units

Code Information:

Lot number: 52418 Exp. Date: 5/1/2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated