American Contract Systems recalls specific pacemaker packs due to potential sterilization issues. Affected units have unique tray numbers and lot codes; consumers should check their product details to determine if they are impacted.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various pacemaker and cardiothoracic packs that may have been exposed to multiple sterilization cycles without proper validation. This could lead to improper functioning of the medical devices, posing risks to users.
The packs were exposed to multiple sterilization cycles without validation, which could cause the medical devices to malfunction. This might lead to improper functioning of the pacemaker or cardiothoracic packs, potentially affecting patient safety.
Patients using the recalled pacemaker packs are most at risk. The recall affects specific units identified by tray numbers and sterilization lot codes.
Check the tray number, sterilization lot, lot number, and bag serial number on the product. Affected units include specific combinations like LSREPCUSTOML with sterilization lot 2106181.
Identify the tray number, sterilization lot, lot number, and bag serial number to determine if your product is affected.
The packs may have been exposed to multiple sterilization cycles without validation, which could cause improper functioning and potential patient safety risks.
Check the tray number, sterilization lot, lot number, and bag serial number on the product. Affected units include specific combinations listed in the recall notice.
The recall does not require immediate discontinuation; affected units should be checked against the provided identifiers to determine if they are impacted.
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-1691-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1691-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
