Medical Radiology Pack Kits Re-Sterilized Without Proper Validation
American Contract Systems Inc. is recalling 32,433 medical radiology packs that were re-sterilized with ethylene oxide gas after a processing error, without validation for multiple sterilization cycles. Product quality, safety, and effectiveness cannot be confirmed.
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 a risk-of-harm medical device product where no illnesses or injuries have been reported. The products have not been validated for the re-sterilization process used, creating a significant theoretical safety concern regarding product quality and effectiveness.
Plain-English summary
American Contract Systems Inc. is recalling 32,433 medical radiology convenience kits (model LKRA40G, UDI-DI 191072189691). The products were re-sterilized using ethylene oxide gas following a nonconformance discovered during the initial sterilization process.
These products have not been validated for exposure to multiple sterilization cycles. As a result, the manufacturer cannot confirm that product quality, safety, and effectiveness are maintained after the re-sterilization.
The recalled products were distributed nationwide in South Dakota, Iowa, Minnesota, Washington, and Illinois. The affected lot is 8025211. Bag serial number 68154347 is affected; if the bag serial number is listed as N/A, the entire lot is considered affected.
The recalled product
- Product
- Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
- Manufacturer
- American Contract Systems Inc.
- Hazard
- improper-sterilization
- 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 (1)
- then whole lot is affected
Distribution
Distributed nationwide across the United States.
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