American Contract Systems recalls breast abdominoplasty packs with unvalidated sterilization cycles. Affected units have specific tray and lot numbers. Stop using immediately to prevent infection risks.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling breast abdominoplasty packs that were exposed to multiple sterilization cycles without proper validation. This could lead to infection risks if the packs are used without proper sterilization checks.
The packs were sterilized multiple times without validation, meaning the sterilization process wasn't confirmed to be effective. This could allow harmful bacteria to remain in the packs, increasing infection risks during surgery.
Surgical teams and medical facilities using the recalled breast abdominoplasty packs are most at risk. Patients receiving procedures with these packs could face infection risks.
Check the tray number, sterilization lot, lot number, and bag serial number on the pack. Affected units have specific identifiers: SWBA26F, 2106091, 842211, 64133051-006.
Discard the pack if you have the specific identifiers listed in the recall notice.
The recalled packs have the tray number SWBA26F, sterilization lot 2106091, lot number 842211, and bag serial number 64133051-006.
Check the tray number, sterilization lot, lot number, and bag serial number on the pack. If they match SWBA26F, 2106091, 842211, and 64133051-006, it is affected.
Discard the pack immediately to prevent infection risks. Contact American Contract Systems for further 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-1697-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1697-2022 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.