Z-3227-2024 Class II Ongoing
FDA device recall Z-3227-2024 was initiated by American Contract Systems, Inc. on August 7, 2024 and is designated Class II. Reason for recall: 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 steriliza… The recall status is ongoing. Affected quantity: 93 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93 units
Product Description
Endovascular AAA Pack, ESED52B; Medical convenience kit
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Code Information
UDI-DI: 00191072218339; Lot: 2405153; Exp: 05/15/2025