American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

How to identify if yours is affected

1. Review item numbers listed in the recall notice.
2. Check UDI-DI and lot numbers printed on each kit’s bag and packaging.
3. Compare your inventory to the affected model list.

Where to find product info

Identify UDI-DI, lot numbers, and bag serial numbers on the kit packaging and labels.

What timeline to expect

4-8 weeks for recall remedy processing and replacement instructions.

If the manufacturer is unresponsive

• Document every contact attempt.
• Escalate to hospital risk management and FDA if the supplier does not respond within a reasonable period.

How to prevent similar issues

• Verify sterilization validation for reused medical devices.
• Prefer single-use sterile packs when possible.
• Keep a current inventory of medical device packs and monitor recall notices.

Documentation advice

Save all recall notices, photos of labels, serial numbers, and all correspondence with the supplier.