Surgical Device Kits Recalled Due to Improper Sterilization Process
American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.
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 FDA recall of surgical devices with improper sterilization due to ethylene oxide concentration exceeding specification. Although no illnesses or injuries have been reported in the source, improper sterilization of surgical instruments creates a direct risk of infection to patients, warranting a High severity classification.
Plain-English summary
American Contract Systems, Inc. is recalling the ACS Arthroscopy Kit (Model LMAR15R, Lot 981221), ACS Knee Kit (Model LWKN46N, Lot 966221), and ACS Hand Pack (Model FHHP63T, Lot 966221). A total of 114 packs are affected.
The recalled products were sterilized with an ethylene oxide concentration higher than the manufacturer's specification. This sterilization process defect may compromise the sterility of the surgical instruments.
The affected products were distributed to Illinois, Missouri, Nebraska, and Texas.
The recalled product
- Product
- 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- improper-sterilization
- 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 (6)
- 1) ACS Arthroscopy Kit - Model LMAR15R
- Lot 981221
- UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N
- Lot 966221
- UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T
- UDI: 00191072149954
Distribution
Distributed nationwide across the United States.
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