American Contract Systems recalls sterile surgical gowns manufactured in an unregistered FDA facility. These packs may pose a risk of contamination during procedures. Affected units include specific tray 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 in a facility not registered with the FDA. This could lead to contamination risks during surgeries if the gowns are used without proper oversight.
The gowns were manufactured in a facility not registered with the FDA, which means they may not meet the required safety and quality standards. This could result in contamination or improper sterility during surgical procedures if the gowns are used without proper oversight.
Surgical teams and hospitals that use these specific sterile custom packs for procedures are likely affected. The risk is primarily for medical professionals handling the packs during surgeries.
Check for ACS Tray Numbers starting with FBPL271 and Lot # 656191 with an expiration date of 12/10/2020. These packs come in sets of 32 kits.
Identify the ACS Tray Number and Lot # to confirm if your pack is affected.
The surgical gowns were manufactured in a facility not registered by the FDA, which may affect their sterility and safety during procedures.
The recall record does not specify a remedy, so check the product details to see if it's affected and contact the manufacturer for further guidance.
32 kits with specific tray number FBPL271 and Lot # 656191 expiring 12/10/2020.
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-2169-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2169-2020 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.
