Surgical Medical Kits Recalled Due to Unvalidated Re-Sterilization
American Contract Systems is recalling surgical medical kits that underwent multiple sterilization cycles without validation. The company cannot confirm the product quality, safety, or effectiveness of these affected kits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical medical devices that underwent unvalidated re-sterilization. No illnesses or injuries have been reported; the hazard is theoretical (product quality and effectiveness cannot be confirmed), fitting the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
American Contract Systems Inc. is recalling multiple surgical medical kits distributed nationwide, including spine packs, laminectomy packs, neuro angio kits, and shunt packs. A total of 32,433 units are affected.
The recalled kits underwent multiple sterilization cycles using ethylene oxide gas after a nonconformance occurred during the initial sterilization process. The products were not validated for exposure to multiple sterilization cycles, and therefore the company cannot confirm their quality, safety, and effectiveness.
The affected products were distributed in South Dakota, Iowa, Minnesota, Washington, and Illinois.
The recalled product
- 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
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical Kit
- Hazard
- sterilization-defect
- product-quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596
- ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493
- HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767
- MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542
- RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026
- SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A
- UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919
- UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A
- UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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