American Contract Systems recalls ophthalmic convenience kits with possible loss of functionality or drug efficacy due to improper sterilization process. Affected kits include EYE PACK (LVEY27) and Laminectomy trays (UIOL34AG).
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 ophthalmic convenience kits that may have lost functionality or drug efficacy because they were improperly sterilized. This could affect medical use of the kits, especially for eye procedures.
The kits were assembled with components that were not properly tested for heat and sterilization exposure. This could cause parts to stop working or medications to lose effectiveness. The issue was found during an internal investigation by the manufacturer.
Ophthalmic healthcare professionals who use these kits for eye procedures are most at risk. Patients using these kits may experience reduced effectiveness of treatments.
Check for kits labeled 'EYE PACK' with kit number LVEY27 or 'Laminectomy' with kit number UIOL34AG. These kits have specific expiration dates listed in the recall notice.
Look for kit numbers LVEY27 or UIOL34AG on the product packaging.
The manufacturer states these kits may have lost functionality or drug efficacy, so they should not be used until the recall is addressed.
The recall does not specify a remedy, so contact the manufacturer directly for guidance.
Check for kit numbers LVEY27 (EYE PACK) or UIOL34AG (Laminectomy) with specific expiration dates listed in the recall notice.
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-0832-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0832-2024 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.
