FDA recall Z-0183-2026

American Contract Systems Inc. · Class II · device

Product

Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)

Reason for recall

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.

Distribution

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Key facts

Status
Ongoing
Initiation date
2025-09-04
Report date
2025-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grimes, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2026