American Contract Systems recalls sterile surgical gowns manufactured in an unregistered FDA facility. These packs (AVLC19G, Lot 642191) expire Dec 2020 and pose risks if used in surgery.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
American Contract Systems is recalling sterile surgical gowns that were made in a facility not registered with the FDA. This could lead to safety issues during surgical procedures if the gowns are used without proper oversight.
The surgical gowns were manufactured in a facility that isn't registered with the FDA. This means they might not meet safety standards for medical use, potentially causing complications during surgery.
Surgical teams and hospitals that use these sterile custom packs for procedures are most at risk. Patients undergoing surgery with these packs may face safety concerns.
Check for ACS Tray Number AVLC19G and Lot # 642191 with an expiration date of December 24, 2020. These packs contain 64 kits and are used in surgical procedures.
Look for ACS Tray Number AVLC19G and Lot # 642191 with expiration date 12/24/2020.
The surgical gowns were manufactured in a facility not registered by the FDA, which could affect safety standards during surgical procedures.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected product.
64 kits with the specific lot number and tray number are affected.
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-2179-2020 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2179-2020 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.
