American Contract Systems recalls sterile surgical gowns made in an unregistered FDA facility. These packs may not meet safety standards for surgical use. Affected kits 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 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 for surgical use.
The gowns were manufactured in a facility that isn't registered with the FDA. This means they might not meet the required safety standards for surgical use, potentially leading to complications during procedures.
Surgical teams and hospitals that purchased these specific sterile surgical packs are likely affected. Patients undergoing surgery using these packs are at risk if the gowns don't meet safety standards.
Check for specific tray numbers: AGSBOO6K, AGDB14J, AHLA17J, SVNE16K, WPLA17I, or 685191. Also look for expiration dates matching the listed dates (e.g., 12/06/2020, 09/20/2020).
Identify the tray number and expiration date on the pack to confirm if it matches the recalled items listed in the notice.
The surgical gowns were manufactured in a facility not registered by the FDA, which means they may not meet safety standards for surgical use.
Sterile Custom Packs with tray numbers AGSBOO6K, AGDB14J, AHLA17J, SVNE16K, WPLA17I, or 685191, with expiration dates listed in the recall notice.
Check the tray number and expiration date on the pack. The affected products include specific tray numbers and expiration dates listed in the recall notice.
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-2176-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2176-2020 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.
