American Contract Systems recalls sterile surgical gowns made in an unregistered FDA facility. These packs may not meet safety standards for surgical use. Affected units include specific tray numbers and expiration dates.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile surgical gowns that were manufactured in a facility not registered with the FDA. This could mean the gowns don't meet safety standards for surgical procedures, posing a risk to patient safety.
The gowns were made in a facility that isn't registered with the FDA. This means they might not meet the safety standards required for surgical use. Using them could lead to potential patient safety issues.
Surgical teams and hospitals that use these sterile custom packs for procedures. Patients undergoing surgery are at risk if the gowns are used without proper FDA registration.
Check for ACS Tray Numbers AGLH66F (Lot # 674191, expiring on [date]) or AGAD45I (Lot # 681191, expiring 11/15/2020). These packs were sold in specific quantities for surgical procedures.
Identify your ACS Tray Number and expiration date to confirm if your pack is affected.
The FDA did not register the facility where these gowns were made, so they may not meet safety standards for surgical use.
244 kits with Tray Number AGLH66F (Lot # 674191) and 35 kits with Tray Number AGAD45I (Lot # 681191).
Check your product details to see if you have an affected unit. If so, contact American Contract Systems for further instructions.
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-2171-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2171-2020 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.
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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.
