American Contract Systems recalls two obstetrical kits due to potential loss of drug efficacy from improper sterilization. Affected kits have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
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 two labor and delivery kits because some components may have been improperly sterilized, which could reduce drug effectiveness. This means the kits might not work as intended during medical procedures.
The kits were sterilized without proper assessment of components that were added during manufacturing. This could lead to components losing functionality or having higher than intended chemical residues after sterilization, potentially reducing drug effectiveness.
Healthcare providers using labor and delivery kits with specific lot numbers. The risk is low as the issue relates to potential reduced functionality rather than immediate harm.
Check for kit numbers HILD52F or HILD52G with specific lot numbers listed in the recall notice. The kits are labeled as 'LABOR & DELIVERY PACK' and have expiration dates listed in the recall.
Reach out to American Contract Systems for specific instructions on how to handle the recalled kits.
The recall occurs because components were added to the kits without proper assessment of their suitability for sterilization, which could lead to reduced functionality or drug effectiveness.
Contact American Contract Systems directly for instructions on handling the recalled kits, as the recall does not specify a specific action like discarding or returning.
The recall indicates a potential risk of reduced drug effectiveness, but it does not mention immediate injury or serious harm, so the risk level is low.
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-0829-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0829-2024 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.
