Cardinal Health 200, LLC: Medical Device Recall in 2022 - (Recall #: Z-0188-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104

Product Classification:

Class II

Date Initiated: September 28, 2022

Date Posted: November 16, 2022

Recall Number: Z-0188-2023

Event ID: 90955

Reason for Recall:

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Status: Ongoing

Product Quantity: 1209260 units

Code Information:

All lots

Distribution Pattern:

nationwide and Canada

Voluntary or Mandated:

Voluntary: Firm initiated