Angiography Packs Recalled Due to Sterilization Validation Failure
American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.
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 medical device recall involving angiography packs used in invasive procedures where sterility is critical. The sterilization validation failure represents a risk-of-harm product. No illnesses or injuries have been reported, which limits the score to a maximum of 3 per the rubric criteria for theoretical hazards without reported harm.
Plain-English summary
American Contract Systems, Inc. is recalling 57 angiography packs and trays distributed to health systems and distributors. The affected products were distributed to facilities in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
The recall was initiated because the sterilization process used on these devices was not validated for multiple sterilization cycles. When medical devices are exposed to sterilization procedures without proper validation for repeated exposures, their sterility integrity may be compromised, potentially increasing the risk of infection during invasive angiography procedures.
Healthcare facilities and distributors that received these angiography packs should contact American Contract Systems, Inc. for guidance on the affected units and appropriate remedial actions.
The recalled product
- Product
- Various Angiography packs/trays
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 57
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 (20)
- Tray Number
- Sterilization Lot
- Lot Number
- and Bag Serial Number: 1) LSRARTDATANGA
- 2105051
- 884211
- 44136929 2) LSRANGIRM21G
- 2105111
- 874211
- 63991913 3) LSRCFHANGD
- 2106031
- 854211
- 14887381 4) LSRARTDATANGA
- 2107102
- 821211
- 44256256 5) LSRARTDATANGA
- 44256255 6) LSRARTDATANGA
- 2110011
- 742211
- 44373255 7) LSRARTDATANGA
Distribution
Part of a larger recall action
This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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