American Contract Systems recalls medical convenience kits that were re-gassed more than once during sterilization, risking product safety and effectiveness. Affected kits include Heart Pack, CV Set Up Pack, and Pacemaker Pack models.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
American Contract Systems is recalling medical convenience kits that were re-gassed (sterilized more than once) during manufacturing. This could compromise product safety and effectiveness, potentially leading to health risks for users.
The kits were re-gassed after a sterilization process error, meaning they underwent multiple sterilization cycles without proper validation. This could lead to product quality issues, safety risks, and reduced effectiveness for medical use.
Medical professionals and patients using the recalled kits may be affected. Those with implanted devices like pacemakers are at higher risk due to potential device malfunction.
Check for specific item numbers like ANCV78BC (Heart Pack), HGCV05K (CV Set Up Pack), or MHPP97AR (Pacemaker Pack) with the listed lot numbers and bag serial numbers. If the bag serial number is 'n/a', the entire lot is affected.
Identify the item number, lot number, and bag serial number to confirm if your kit is affected.
The kits were re-gassed more than once during sterilization, which hasn't been validated for safety and effectiveness.
Affected models include Heart Pack (ANCV78BC), CV Set Up Pack (HGCV05K), and Pacemaker Pack (MHPP97AR) with specific lot numbers and serial numbers.
The recall does not specify a stop-use instruction, but affected kits should be checked for safety before use.
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-0176-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0176-2026 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.
