American Contract Systems recalls sterile surgical gowns manufactured in an unregistered FDA facility. These packs may pose risks during surgery due to lack of FDA registration. Affected kits include specific lot 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 at a facility not registered with the FDA. This could lead to safety issues 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 they may not meet the required safety standards for medical devices, potentially leading to complications during surgery if used without proper oversight.
Surgical teams and hospitals that use these sterile custom packs for procedures are affected. Patients and staff at facilities using the recalled lots are at risk if the gowns are used without proper regulatory oversight.
Check for ACS Tray Numbers like WXCT12E, PTHS10C, WXPO16G, and other specific lot numbers listed in the recall notice. The products have expiration dates ranging from December 2020 to January 2021.
Identify the ACS Tray Number and expiration date on the packaging to confirm if your product is affected.
The surgical gowns were manufactured in a facility not registered by the FDA, which may not meet safety standards for medical devices.
The recall notice does not specify a remedy, so check the product details to see if it is affected and contact American Contract Systems for further instructions.
Yes, affected lots include WXCT12E (Lot # 998201, Exp. 001/02/2021), PTHS10C (Lot # 664191, Exp. 12/02/2020), and other specific tray numbers with 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-2177-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2177-2020 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.
