American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1696-2022)
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:
Various Port Insertion Packs
Product Classification:
Class II
Date Initiated: June 16, 2022
Date Posted: September 14, 2022
Recall Number: Z-1696-2022
Event ID: 90574
Reason for Recall:
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Status: Ongoing
Product Quantity: 2 units
Code Information:
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) GSPI26E, 2108202, 770211, 44336884-005 2) GSPI26E, 2108202, 770211, 44336909-005
Distribution Pattern:
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Voluntary or Mandated:
Voluntary: Firm initiated