American Contract Systems recalls various angiography and cath lab packs/trays that were exposed to multiple sterilization cycles without validation, potentially causing contamination. Affected units include specific tray numbers and sterilization lots.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various angiography and catheter lab packs/trays that were exposed to multiple sterilization cycles without proper validation. This could lead to contamination risks during medical procedures.
The trays were sterilized multiple times without validation, which could result in contamination. This poses a risk of infection or improper medical procedures if the trays are used without proper validation.
Healthcare professionals using these medical trays in catheter labs or angiography procedures are most at risk. The recall affects specific units identified by tray numbers, sterilization lots, and serial numbers.
Check the tray number, sterilization lot, lot number, and bag serial number on the product. Affected units include specific combinations like LSRCUSTCATHG, 2104091, 911211, 44064504.
Identify the tray number, sterilization lot, lot number, and bag serial number to determine if your unit is affected.
The trays were exposed to multiple sterilization cycles without validation, which could lead to contamination during medical procedures.
Check the tray number, sterilization lot, lot number, and bag serial number. Affected units include specific combinations listed in the recall notice.
No immediate stop is required; the recall focuses on identifying affected units for potential replacement or correction.
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-1690-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1690-2022 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.