Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)
Multiple sterilization cycles can compromise medical device quality and safety.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK
Brand
American Contract Systems Inc.
Lot Codes / Batch Numbers
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448, AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042, ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117, ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621, CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706, CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A, EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257, EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868, FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258, FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897, HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067, HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A, HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513, IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038, IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486, IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149, LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A, LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A, LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780, MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A, NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A, OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial numbers 47507802 47508002 47508012, RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A, SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A, STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128, TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A, UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number 68703044, UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A, UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A, UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422, UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A * If "N/A" for bag serial number, then whole lot is affected
Products Sold
AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448; AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042; ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117; ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621; CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706; CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A; EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257; EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868; FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258; FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897; HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067; HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A; HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513; IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038; IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486; IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149; LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A; LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A; LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780; MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A; NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A; OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial numbers 47507802 47508002 47508012; RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A; SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A; SFMB55Y UDI-DI 191072229991 Lot 8096711 Bag serial number N/A Lot 8179711 Bag serial numbers 17556181 17557278; STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128; TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A; UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number 68703044; UDMA50X UDI-DI 191072172587 Lot 8084711 Bag serial number 17390548 Lot 8183611 Bag serial number 17554620; UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A; UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A; UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422; UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A * If "N/A" for bag serial number, then whole lot is affected
American Contract Systems Inc. is recalling Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST due to Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Recommended Action
Per FDA guidance
Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.