Custom Healthcare Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0242-2019)

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- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: October 31, 2018

Recall Number: Z-0242-2019

Event ID: 81179

Reason for Recall:

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

Status: Terminated

Product Quantity: (1) 750 units (2) 200 units

Code Information:

(1)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated