American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1040-2022)

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:

ACS Cath Lab Pack

Product Classification:

Class II

Date Initiated: March 22, 2022

Date Posted: May 18, 2022

Recall Number: Z-1040-2022

Event ID: 89868

Reason for Recall:

Product was sterilized with a higher than specification EO concentration.

Status: Ongoing

Product Quantity: 10 packs

Code Information:

Model FTCL83K, Lot 982221 UDI: 00191072151360

Distribution Pattern:

US Nationwide distribution in the states of IL, MO, NE, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated