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 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 used in procedures because they were made in a facility not registered with the FDA. This could lead to unsafe medical procedures if the gowns are used without proper oversight.
Surgical gowns made in an unregistered FDA facility may not meet safety standards. This could lead to improper sterilization or contamination during medical procedures, risking patient safety.
Surgical teams and hospitals that use these specific sterile surgical gowns are likely affected. Patients undergoing surgery with these gowns face the highest risk of potential safety issues.
Check for tray numbers AGPP38I, AGHA64J, or WPBU64H on the packaging. The affected lots have specific expiration dates: December 22, 2020, October 14, 2020, or November 26, 2020.
Look for tray numbers AGPP38I, AGHA64J, or WPBU64H on the packaging.
The surgical gowns were manufactured in a facility not registered by the FDA, which could lead to safety risks during medical procedures.
Check for tray numbers AGPP38I, AGHA64J, or WPBU64H with specific expiration dates: December 22, 2020, October 14, 2020, or November 26, 2020.
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-2178-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2178-2020 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.