American Contract Systems recalls CYSTO PACK Model N HKCY31A due to possible sterilization issues causing treatment delays. Affected units have specific lot numbers and UDI-DI codes.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling CYSTO PACK Model N HKCY31A devices because they may not have been properly sterilized, which could lead to treatment delays. This affects medical devices used in healthcare settings.
The devices may not have met sterilization requirements, which could cause delays or prolonged treatment. This is not a safety hazard that causes injury but affects the effectiveness of medical procedures.
Healthcare facilities and medical professionals using the CYSTO PACK Model N HKCY31A devices are likely affected. The risk is low as the hazard involves potential treatment delays rather than immediate injury.
Check for the model number HKCY31A on the device. Affected units have specific lot numbers: 933241, 70-051382, and 7:052664. The UDI-DI code 00191072059093 is also associated with these units.
Look for the model number HKCY31A and lot numbers 933241, 70-051382, or 70-052664 on the device.
American Contract Systems is recalling CYSTO PACK Model N HKCY31A devices because they may not have met sterilization requirements, which could lead to treatment delays.
Check the device for the model number HKCY31A and lot numbers 933241, 70-051382, or 70-052664. If you have these details, contact American Contract Systems for further instructions.
The recall is for potential treatment delays, not a safety hazard that causes injury. The risk level is low.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1335-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1335-2025 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
