American Contract Systems recalls specific ear, nose & throat procedural kits with potential unverified sterilization components that may lose functionality or drug efficacy.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
American Contract Systems is recalling certain ear, nose and throat procedural kits because some components were not properly tested for heat and sterilization exposure. This could mean the kits don't work properly or medications might not be effective. Consumers should check if their kit matches the listed model numbers and lot dates.
The kits contain components that were 'piggybacked' onto the trays without proper testing for heat and sterilization exposure. This could lead to components losing functionality or having higher than intended sterilant residues, potentially affecting medication effectiveness.
Healthcare professionals using the recalled kits for ear, nose and throat procedures are most at risk. Patients using these kits may experience reduced effectiveness of medications or procedures.
Check for kit labels with model numbers: AGTA48J, LLEO66, or MMTA41F. Look for specific lot numbers and expiration dates listed in the recall notice.
Look for model numbers (AGTA48J, LLEO66, MMTA41F) and associated lot numbers and expiration dates on the kit.
The components may lose functionality or have higher than specified sterilant residues, potentially affecting medication effectiveness.
Check for model numbers AGTA48J, LLEO66, or MMTA41F with specific lot numbers and expiration dates listed in the recall notice.
No, the recall does not require immediate discontinuation but checking for the specific model numbers is recommended.
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-0820-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0820-2024 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.
