American Contract Systems recalls sterile surgical gowns manufactured in an unregistered FDA facility. Affected lots expire by November 2020. No remedy specified in recall notice.
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 at a facility not registered with the FDA. This could pose a risk if the gowns are used in surgery without proper regulatory oversight.
Surgical gowns made in an unregistered FDA facility may not meet safety standards. This could lead to complications during surgery if the gowns fail to protect against infection or injury.
Surgical teams and hospitals that use these specific sterile surgical gowns. Patients undergoing surgery with these gowns are at risk if the facility wasn't properly registered with the FDA.
Check for ACS Tray Numbers FBCS38I with Lot # 692191 (expiring 11/04/2020) or Lot # 648191 (expiring 12/18/2020). These gowns were sold for surgical procedures.
Look for ACS Tray Number FBCS38I and lot numbers 692191 or 648191 on the surgical gown packaging.
The recall states they were manufactured in an unregistered FDA facility, which may not meet safety standards. No specific safety confirmation is provided.
Four kits with Lot # 692191 and forty kits with Lot # 648191 are affected.
The recall notice does not specify a remedy, so no action is required beyond checking if you have the affected lots.
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-2174-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2174-2020 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.
