Z-3238-2024Class II
Vaginal Delivery, ASDV25B; Medical convenience kit
American Contract Systems, Inc. / initiated 2024-08-07 / Open, Classified / root cause: sterility
American Contract Systems, Inc. began a recall of Vaginal Delivery, ASDV25B; Medical convenience kit on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-3238-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- Vaginal Delivery, ASDV25B; Medical convenience kit
- Product code
- MLS Labor And Delivery 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.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."
- Quantity in commerce
- 1 unit
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Product codes and lots
- UDI-DI: 00191072218841; Lot: 2405102; Exp: 05/10/2025
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3226-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3227-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3228-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3229-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3230-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3231-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3232-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3233-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3234-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3235-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3236-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3237-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3238-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3239-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3240-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3241-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3242-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3243-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3244-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.