American Contract Systems recalls sterile surgical gowns made in an unregistered FDA facility. Affected lots include specific tray numbers and expiration dates. Consumers should contact the manufacturer for details.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile custom surgical gowns made in a facility not registered with the FDA. This could lead to using unsafe medical products during surgery if the gowns are used without proper regulatory oversight.
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.
Healthcare professionals and surgical teams who use these sterile custom packs for procedures are most at risk. Patients receiving surgery using these recalled gowns could be affected.
Check the tray number and expiration date on the packaging. Affected lots include specific combinations like WPPP52E (Lot #723191, Exp. 10/04/2020) and others listed in the recall notice.
Look for the tray number and expiration date on the packaging to determine if your gowns are affected.
The recall states the gowns were manufactured in an unregistered FDA facility, so they may not meet safety standards. Do not use them until you confirm they are not affected.
Check the tray number and expiration date on the packaging. Affected lots include specific combinations like WPPP52E (Lot #723191, Exp. 10/04/2020) and others listed in the recall notice.
Contact American Contract Systems directly to confirm if your gowns are affected and follow their 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-2170-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2170-2020 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.