American Contract Systems recalls sterile surgical gowns made in an unregistered FDA facility. These packs (72 kits) may pose risks during surgery. Consumers should contact the company for details.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile surgical gowns made in a facility not registered with the FDA. This could lead to safety issues during medical procedures if used without proper oversight.
The gowns were manufactured in a facility not registered by the FDA, which means they may not meet safety standards. This could lead to improper sterilization or contamination during surgery, potentially causing infections or other complications.
Surgical teams and hospitals using these sterile custom packs for procedures are affected. Patients and staff at facilities that received the recalled packs are at risk.
Check for ACS Tray Numbers AGCY21I (Lot #664191, exp. 12/02/20) or WXCY21F (Lot #661191, exp. 12/05/20). These packs were sold in limited quantities for surgical use.
Identify the ACS Tray Number and expiration date to confirm if your pack is recalled.
The gowns were manufactured in a facility not registered by the FDA, which may affect their safety and sterility during procedures.
72 kits with Tray Number AGCY21I (Lot #664191, exp. 12/02/20) and 32 kits with Tray Number WXCY21F (Lot #661191, exp. 12/05/20).
The recall record does not specify a remedy, so contact American Contract Systems directly for 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-2167-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2167-2020 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.
