American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1703-2022)

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 C-section packs

Product Classification:

Class II

Date Initiated: June 16, 2022

Date Posted: September 14, 2022

Recall Number: Z-1703-2022

Event ID: 90574

Reason for Recall:

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

Status: Ongoing

Product Quantity: 24 units

Code Information:

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPCSECTB, 2106301, 826211, 64124711 2) FHCP08U, 2107143, 807211, 64166455 3) LMSE38N, 2108202, 770211, 64231900 4) CFCS39G, 2108243, 768211, 64232041 5) IHCS29AA, 2109272, 733211, 64214921 6) CXCS92U, 2106191, 830211, 64071586-006 7) BHCS88D, 2104163, 897211, 64072275-006 8) BHCS88D, 2104163, 897211, 64072274-006 9) BHCS88D, 2104163, 897211, 64072275-006 10) BHCS88D, 2105151, 869211, 64067191-006 11) BHCS88D, 2106091, 848211, 64045555-006 12) BHCS88D, 2106232, 835211, 64091025-006 13) BHCS88D, 2106232, 835211, 64091024-006 14) BHCS88D, 2107061, 835211, 64090343-006 15) BHCS88D, 2107132, 811211, 64089826-006 16) BHCS88D, 2107132, 811211, 64089827-006 17) BHCS88D, 2107132, 811211, 64089828-006 18) BHCS88D, 2107161, 806211, 64088821-006 19) BHCS88D, 2107161, 806211, 64088822-006 20) BHCS88D, 2108171, 777211, 64092742-006 21) BHCS88D, 2109072, 758211, 63997845-006 22) BHCS88D, 2109072, 758211, 63997846-006 23) SWCS92K, 2107151, 811211, 64129480-006 24) SSCS25D, 2108171, 774211, 64139013-006

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