Z-0424-2025Class II
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2024-09-20 / Open, Classified / root cause: manufacturing process
AVID Medical, Inc. began a recall of Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11 on . FDA classified it as Class II and gives the reason as "Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0424-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Avid Medical, Inc. a Medical Action Ind. Company 305
- Product
- Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
- Product code
- OKV Obstetrical Kit
- Reason for recall
- Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Avid Medical issued Urgent: Voluntary Medical Device Recall letter via email on 9/20/24. Letter states reason for recall, health risk and action to take: If you received any of the batches/lots identified in APPENDIX 1, please review your inventory, and discard the entire kit. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified in Appendix 1 were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness. "Complete the attached Recall Response Form and return as soon as possible. Report any quality problems or adverse events associated with the products listed in this notification to [email protected].
- Quantity in commerce
- 14 eaches
- Distribution
- US Nationwide distribution.
- Product codes and lots
- GTIN: 10809160381991 Lot Number: 1583045
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0383-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0384-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0385-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0386-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0387-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0388-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0389-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0390-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0391-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0392-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0393-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0394-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0395-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0396-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0397-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0398-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0399-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0400-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0401-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0402-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0403-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0404-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0405-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0406-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0407-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0408-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0409-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0410-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0411-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0412-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0413-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0414-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0415-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0416-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0417-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0418-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0419-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0420-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0421-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0422-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0423-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0424-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0425-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0426-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0427-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0428-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0429-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0430-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0431-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0432-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0433-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0434-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0435-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0436-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0437-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0438-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0439-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0440-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0441-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0442-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0443-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0444-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0445-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0446-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0447-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0448-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0449-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0450-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0451-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0452-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0453-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0454-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0455-2025 | 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.