FDA Enforcement
Class II
Ongoing
Cath Lab Pack, CECL02P; Medical convenience kit
Recall: Z-3239-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3239-2024
- Event ID
- 95261
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 2, 2024
- Initiation Date
- August 7, 2024
- Classification Date
- September 24, 2024
- Address
- 2610 Ne Industrial Dr Ste 220, Kansas City, MO, 64117-2648, United States
Description
Cath Lab Pack, CECL02P; Medical convenience kit
Reason
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code Info
UDI-DI: 00191072206497; Lot: 2405102; Exp: 05/10/2025
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Quantity
1 unit