FDA Enforcement
Class II
Ongoing
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Recall: Z-2519-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2519-2024
- Event ID
- 94908
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- May 6, 2024
- Classification Date
- August 7, 2024
- Address
- 2610 Ne Industrial Dr Ste 220, Kansas City, MO, 64117-2648, United States
Description
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Reason
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Code Info
UDI-DI 00191072190536; Lot 981241; Exp. Date 1/19/2025.
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Quantity
120