American Contract Systems Recalls 32,433 Angio Packs Over Re-Gassed EO Sterilization (2025)

How to identify if yours is affected

1. Verify model numbers against HSAN63N IHAN02W MHCA98AK RCAN45C UDCO10F
2. Confirm whether the device has undergone a second EO sterilization cycle
3. Refer to the recall notice for specific instructions and remedies
4. Do not use affected devices until instructed otherwise by the manufacturer or healthcare facility leadership
5. Document receipt of recall notice and actions taken

Where to find product info

FDA enforcement report Z-0180-2026 and the manufacturer recall notice linked in the enforcement action

What timeline to expect

Recall status is ACTIVE. Processing times for replacement or refunds will be provided by the manufacturer.

If the manufacturer is unresponsive

• Escalate to hospital compliance or risk management.
• If the manufacturer is unresponsive, contact the FDA consumer complaint coordinator or CPSC for guidance.

How to prevent similar issues

• Verify sterilization validation with suppliers.
• Require sterilization confirmation for EO cycles.
• Maintain updated recall communications and access to manufacturer contact information.

Documentation advice

Keep a copy of the recall notice, model numbers, serial/date codes, and all correspondence with the manufacturer.