Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC Recalled by American Contract Systems Inc. Due to Identified products were re-gassed (sterilized more than once)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Contract Systems Inc. directly.
Affected Products
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)
Quantity: 32,433 total
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Contract Systems Inc.
American Contract Systems Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report