American Contract Systems recalls TPK Anterior Hip Pack 1764: Procedure Kit (TPAH21E) due to potential EO/ECH chemical residues exceeding safety limits. Affected units include specific lot numbers. Consumers should contact the manufacturer for details.
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 their TPK Anterior Hip Pack 176483-Procedure Kit (catalog number TPAH21E) because chemical residues from ethylene oxide and ethylene chlorohydrin may exceed safe levels for long-term use. This could pose a risk of health issues if the device is used without proper cleaning.
The hip pack procedure kit may contain ethylene oxide and ethylene chlorohydrin residues that exceed safety limits for long-term use. These chemicals can cause health issues if the device is used without proper cleaning or if residues remain on the skin.
Patients using this hip pack procedure kit for medical purposes are likely affected. Those with prolonged contact with the device may be at higher risk due to potential chemical exposure.
Check for the catalog number TPAH21E on the product. Affected units include specific lot numbers: 640231, 973241, 742231, and 934241. The product was sold with a unique identifier (UDI-DI) of 00191072171726.
Reach out to American Contract Systems for specific instructions on how to handle the recalled product.
The catalog number is TPAH21E.
Affected lot numbers are 640231, 973241, 742231, and 934241.
Check the catalog number on the product and compare it to TPAH21E. Also, verify the lot numbers listed: 640231, 973241, 742231, and 934241.
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-2305-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2305-2024 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.
