Z-3238-2024 Class II Ongoing
FDA device recall Z-3238-2024 was initiated by American Contract Systems, Inc. on Aug 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… The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 2, 2024
- Initiation Date
- Aug 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Vaginal Delivery, ASDV25B; 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: 00191072218841; Lot: 2405102; Exp: 05/10/2025
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3238-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026