Custom Healthcare Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0259-2019)

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-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: October 31, 2018

Recall Number: Z-0259-2019

Event ID: 81179

Reason for Recall:

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

Status: Terminated

Product Quantity: 1250 units

Code Information:

Lot number:51018 Exp Date: 5/1/2021 Exp. Date: 2/1/2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated