American Contract Systems, Inc. Various Cysto Packs Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Various Cysto Packs
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
American Contract Systems, Inc. is recalling Various Cysto Packs due to Product was exposed to multiple sterilization cycles without validation for multiple exposures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Recommended Action
Per FDA guidance
The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026