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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 20
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
Part of a larger recall action
This product is one of 5 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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