American Contract Systems recalls sterile surgical gowns due to being made in an unregistered FDA facility. Affected kits include specific lot numbers and expiration dates. Consumers should check their product labels for these details.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile surgical gowns used in procedures because they were made in a facility not registered with the FDA. This could mean the gowns don't meet safety standards and might not be safe for use during surgery.
The surgical gowns were manufactured in a facility that is not registered by the FDA. This means the gowns may not meet the required safety standards for medical use, potentially leading to complications during surgery.
Surgical teams and hospitals that purchased the recalled sterile custom packs. Patients undergoing surgery with these gowns are at risk if the gowns are used without proper safety checks.
Check the product label for the ACS Tray Number (e.g., SVOH98F, AHMV261) and lot number (e.g., 676191). The expiration date is listed as 11/20/20 or similar dates for specific kit quantities.
Look for the ACS Tray Number and lot number on the packaging to determine if your gowns are affected.
The recall states the gowns were made in an unregistered FDA facility, so they may not meet safety standards. They should not be used until the manufacturer confirms they are safe.
The recall includes specific lot numbers and quantities: 3 kits, 10 kits, 36 kits, 25 kits, 3 kits, 72 kits, 48 kits, and 42 kits.
Check the product label for the ACS Tray Number and lot number to see if your gowns are affected. If they are, stop using them and 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-2166-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2166-2020 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.
