American Contract Systems Medical Procedure Kits Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling 1,233 medical procedure kits distributed in 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 a Class II recall involving risk-of-harm products (surgical procedure kits require sterilization for patient safety) where no injuries or illnesses have been reported. The sterilization assurance failure creates a theoretical risk of infection during surgical procedures, which meets the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
American Contract Systems Inc. is recalling certain medical procedure kits and trays due to sterilization assurance issues. During an internal investigation, the company determined that the rationale for sterilization of certain components was not justified, meaning some components may not be fit for further sterilization according to company procedures.
The affected kits include multiple models distributed to Illinois and Louisiana, totaling 1,233 units. Affected products include LAP CHOLE PACK (multiple models and lot numbers), LAPAROSCOPY PACK, and GENERAL LAPAROSCOPY MPH kits.
The company is unable to confirm that product sterilization assurance requirements were met for the affected kits. Non-sterile surgical instruments and kits could pose a risk of infection during medical procedures. No illnesses or injuries have been reported to date.
Healthcare facilities and surgical centers that have received these kits should immediately discontinue use and contact American Contract Systems Inc. for instructions on return or replacement of affected units.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
- 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 (20)
- 1) Model/Item Number CILC69L: UDI/DI 00191072235503
- Kit Lot Numbers: 42-7937111
- 42-8049311
- 2) Model/Item Number HNLC80J: UDI/DI 00191072193650
- Kit Lot Numbers: 42-8044511
- 42-8118911
- 42-7977011
- 42-7803211
- 3) Model/Item Number JKLC55H: UDI/DI 00191072235138
- Kit Lot Numbers: 42-7814311
- 4) Model/Item Number LLLA21K: UDI/DI 00191072233486
- Kit Lot Numbers: 70-052582
- 70-053048
- 70-051564
- 70-051373
- 70-051163
- 70-053446
- 70-053776
- 5) Model/Item Number MPGL15G: UDI/DI 00191072223197
- Kit Lot Numbers: 5436916
Distribution
Distributed in 2 states:
- IL
- LA
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