Spine and laminectomy packs recalled after being sterilized more than once
American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.
Plain-English summary
Medical convenience kits used in spinal and neurological procedures are being recalled. Affected item numbers include HSLM53AB (Spine Pack), MILM82A (DTC Laminectomy Pack), RCNA47B (Neuro Angio), SFLM54AB (Laminectomy Pack), UDLM94AA (Laminectomy Pack) and UILM77AU (Laminectomy).
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.
The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.
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
- resterilization
- unvalidated-process
- sterility-assurance
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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