FDA Enforcement
Class II
Ongoing
American Contract Systems Gyn Laparoscopy convenience kit
Recall: Z-2518-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2518-2024
- 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 Gyn Laparoscopy 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
(1) Model No SLGL64K - UDI-DI 00191072202017; Lot 981241; Exp. Date 1/19/2025; and (2) Model No SMGY46A - UDI-DI 00191072188458; Lot 982241; Exp. Date 1/18/2025.
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Quantity
29 kits