American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1695-2022)

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 Cysto Packs

Product Classification:

Class II

Date Initiated: June 16, 2022

Date Posted: September 14, 2022

Recall Number: Z-1695-2022

Event ID: 90574

Reason for Recall:

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Status: Ongoing

Product Quantity: 21 units

Code Information:

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCFHCYTURC, 2105051, 883211, 15142078 2) LSRCFHCYTURC, 2106092, 853211, 44251068 3) LSRCYSTOTURF, 2106181, 834211, 44251068 4) LSRCYSTOTURF, 2108251, 775211, 44376072 5) JECY99B, 2105182, 862211, 44108484-005 6) BHCY71H, 2107011, 819211, 44247051-005 7) SLCY61, 2108111, 777211, 15093750-004 8) BHCY31D, 2107161, 810211, 44228702-005 9) BHCY31D, 2107161, 810211, 44228704-005 10) BHCY31D, 2107161, 810211, 44228703-005 11) BHCY31D, 2109032, 763211, 44333133-005 12) BHCY31D, 2109032, 763211, 44333132-005 13) BHCY31D, 2109032, 763211, 44333131-005 14) BHCY31D, 2109032, 763211, 44333300-005 15) BHCY31D, 2109032, 763211, 44333398-005 16) BHCY31D, 2110051, 726211, 44351428-005 17) BHCY31D, 2110051, 726211, 44351427-005 18) BHCY31D, 2110051, 726211, 44351426-005 19) BHCY31D, 2110051, 726211, 44351425-005 20) UTCY45M, 2104231, 890211, 44175283-005 21) FRCY56D, 2105121, 869211, 44173978-005

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