Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue
American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.
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: Class II recall for sterilization residuals exceeding safety limits for permanent-implant devices. No illnesses or injuries reported; hazard is chemical residue exposure exceeding established standards, fitting the High category for risk-of-harm products without reported injury.
Plain-English summary
American Contract Systems Inc is recalling 107 units of the FOOT ANKLE-LF Procedure tray (Catalog Number CCFA51B) distributed nationwide. The recall was issued because ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeded the permitted limits for permanent-implant medical devices.
Ethylene oxide and ethylene chlorohydrin are chemical byproducts of the sterilization process. When these residuals exceed established safety limits, they pose a potential health risk. This product is classified for permanent implantation, which requires stricter residual limits per ANSI/AAMI/ISO 10993-7 (2012) standards.
The recalled units include lot numbers 651231, 983241, 940241, and 901241 (UDI-DI: 00191072193148). Healthcare providers and facilities with these trays should refer to the FDA recall notice for instructions on handling affected inventory.
The recalled product
- Product
- FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-residue
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 (1)
- UDI-DI: 00191072193148 LOT#"s: 651231 983241 940241 901241
Distribution
Distributed nationwide across the United States.
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