Medical Surgery Kits Recalled for Sterilization Assurance Failure
American Contract Systems is recalling 1,094 laparoscopy and pelviscopy procedure kits distributed to Illinois and Louisiana because the company cannot confirm sterilization requirements were met for certain components.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard—inability to confirm sterilization of surgical equipment—is theoretical and risk-of-harm in nature, meeting the criterion for Score 3 (High) under the rubric.
Plain-English summary
American Contract Systems Inc is recalling 1,094 medical procedure kits and trays used in laparoscopic and pelviscopic surgery. The recalled products include Laparoscopy Pack (Model EVLP61I) and Pelviscopy kits (Model EVPV29G), which are sterile surgical supplies used in minimally invasive surgical procedures.
During an internal investigation, American Contract Systems determined that the sterilization procedures for certain components in these kits could not be justified and therefore cannot meet the company's sterilization assurance requirements. As a result, the company is unable to confirm that product sterilization assurance requirements were met.
The recalled products were distributed to medical facilities in Illinois and Louisiana. Healthcare providers and facilities that received these products should contact American Contract Systems regarding the recall and follow the manufacturer's instructions for proper handling and disposition of affected kits.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
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 (11)
- 1) MODEL/ITEM NUMBER EVLP61I: UDI/DI 00191072194831
- Kit Lot Numbers: 12-7359211
- 12-7077211
- 12-7115211
- 12-7162811
- 12-7224111
- 42-8276811
- 42-8200111
- 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930
- Kit Lot Numbers: 12-7288711
- 12-7288711
Distribution
Distributed in 2 states:
- IL
- LA
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