American Contract Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
203 (2 Class I)
510(k) Clearances
0
Inspections
38
Compliance Actions
4

Recent Recalls

NumberClassProductDate
Z-0173-2026Class IIMedical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 September 4, 2025
Z-0176-2026Class IIMedical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET USeptember 4, 2025
Z-0186-2026Class IIMedical convenience kits UDPG88W PICC G-TUBE PACK-230209September 4, 2025
Z-0170-2026Class IIBasic Biopsy Tray, Item Number NMBP44LSeptember 4, 2025
Z-0175-2026Class IIMedical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LABSeptember 4, 2025
Z-0185-2026Class IIMedical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PSeptember 4, 2025
Z-0172-2026Class IIMedical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREASTSeptember 4, 2025
Z-0179-2026Class IIMedical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GSeptember 4, 2025
Z-0184-2026Class IIMedical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERSeptember 4, 2025
Z-0180-2026Class IIMedical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK September 4, 2025
Z-0183-2026Class IIMedical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PSeptember 4, 2025
Z-0178-2026Class IIMedical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECSeptember 4, 2025
Z-0177-2026Class IIMedical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KISeptember 4, 2025
Z-0187-2026Class IIMedical convenience kits IHDC30R D AND C PACKSeptember 4, 2025
Z-0182-2026Class IIMedical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKSeptember 4, 2025
Z-0181-2026Class IIMedical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK September 4, 2025
Z-0171-2026Class IIBasic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLSeptember 4, 2025
Z-0174-2026Class IIMedical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 20597September 4, 2025
Z-2469-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, MJuly 14, 2025
Z-2466-2025Class IIAMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item NumbJuly 14, 2025