American Contract Systems recalls Hand Pack 297829 Procedure Kit (RGHN04I) due to potential skin irritation from ethylene oxide/ethylene chlorohydrin residuals. Affected units have specific lot numbers and UDI-DI codes.
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
American Contract Systems is recalling a specific procedure kit because chemical residues could cause skin irritation. This is a safety issue for people using the kit for medical purposes.
The kit contains ethylene oxide and ethylene chlorohydrin residues that may cause skin irritation if exposed to during normal use. These chemicals are used in medical devices but can leave harmful levels of residues if not properly cleaned.
Users of the Hand Pack 297829 Procedure Kit (catalog number RGHN04I) are likely affected. Healthcare professionals and patients using the kit for medical procedures are at the highest risk.
Check for the catalog number RGHN04I on the kit. Affected units have specific lot numbers: 646231 or 927241 and UDI-DI code 00191072203175.
Look for catalog number RGHN04I and lot numbers 646231 or 927241 on the kit.
The product may cause skin irritation due to chemical residues, so it is not safe for use without checking if it is recalled.
The recall does not specify a remedy, so check the kit details to see if it is affected.
Affected kits have catalog number RGHN04I and lot numbers 646231 or 927241 with UDI-DI code 00191072203175.
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-2295-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2295-2024 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.
