Custom Healthcare Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0261-2019)

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-BONE MARROW TRAY Product Number:B9-4000

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: October 31, 2018

Recall Number: Z-0261-2019

Event ID: 81179

Reason for Recall:

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

Status: Terminated

Product Quantity: 48 units

Code Information:

Lot number: 61518 Exp Date: 12/1/2020

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated