ACS Lap Chole Pack surgical instruments recalled for sterilization process defect
American Contract Systems recalls ACS Lap Chole Pack surgical kits due to sterilization with ethylene oxide concentration exceeding manufacturer specification.
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 FDA Class II medical device recall involves a sterilization process defect that affects surgical instruments. While no illnesses or injuries have been reported, improper sterilization could compromise sterility assurance, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc., is recalling the ACS Lap Chole Pack, a surgical instrument pack used in laparoscopic cholecystectomy procedures. The product was sterilized using ethylene oxide at a concentration higher than the manufacturer's specification.
The recall affects 20 packs distributed nationwide in Illinois, Missouri, Nebraska, and Texas. The affected units are identified by Model BLLC42M, Lot 643211 (UDI: 00191072152473).
While no illnesses or injuries have been reported, sterilization outside of specification raises concerns about sterility assurance and the safety of the surgical instruments. Healthcare facilities and practitioners who have received this product should stop using the affected lot and contact American Contract Systems, Inc., for instructions on returns or replacement. Any adverse events should be reported to the FDA.
The recalled product
- Product
- ACS Lap Chole Pack
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-defect
- ethylene-oxide
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 (2)
- Model BLLC42M
- Lot 643211 UDI: 00191072152473
Distribution
Distributed nationwide across the United States.
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