Custom Healthcare Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0249-2019)

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:

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

Product Classification:

Class II

Date Initiated: August 13, 2018

Date Posted: October 31, 2018

Recall Number: Z-0249-2019

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) 180 units (2)180 units

Code Information:

(1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated