American Contract Systems recalls surgical gowns made in an unregistered FDA facility. These Custom Packs for surgery were manufactured in a non-compliant facility and may pose risks.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling surgical gowns made in a facility not registered with the FDA. This could pose risks to patients during surgical procedures due to potential non-compliance with safety standards.
The surgical gowns were produced in a facility that does not have FDA registration. This means they may not meet the required safety and quality standards for medical devices, potentially leading to risks during surgical procedures.
Surgical teams and hospitals that use these Custom Packs for procedures are affected. Patients undergoing surgery with these gowns may be at risk due to the unregistered manufacturing facility.
Check for the model codes WPGA21L, AGGL48H, AGGM59N, and lot numbers listed in the recall notice. These gowns were sold with specific expiration dates and quantities.
Identify the model code and lot number to confirm if your surgical gown is affected by this recall.
The surgical gowns were manufactured in a facility that is not registered by the FDA, which may pose risks during surgical procedures.
The recall record does not specify a remedy, so check the product details to see if your gown is affected and contact the manufacturer for further instructions.
Look for model codes WPGA21L, AGGL48H, AGGM59N, and lot numbers listed in the recall notice with specific expiration dates.
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-2168-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2168-2020 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.
