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ACL St. Lukes Methodist (American Contract Systems) – EO/ECH Residuals (2024)

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.

High

FDAMay 15, 2024Nationwide• American Contract Systems Inc

Major Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

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.

High

FDAMay 15, 2024Nationwide• American Contract Systems Inc

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ACL St. Lukes Methodist (American Contract Systems) – EO/ECH Residuals (2024)

Major Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Foot Ankle Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Total Knee St. Lukes (American Contract Systems) – EO/ECH Residuals (2024)

Lower Extremity Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

TPK Anterior Hip Pack (American Contract Systems) – EO/ECH Residuals (2024)

Hand Pack (American Contract Systems) – EO/ECH Residuals (2024)

Hand Wrist Forearm Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Total Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Ultrathane Mac-Loc Drainage Catheter (Cook) – Incorrect Expiration (2024)

Arthroscopy Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Total Knee Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Knee Scope Procedure Tray (American Contract Systems) – EO/ECH Residuals (2024)

Arthroscopy Wolfson Pack (American Contract Systems) – EO/ECH Residuals (2024)

Total Knee Procedure Kit (American Contract Systems) – EO/ECH Residuals (2024)

Standard Arthroscopy Pack (American Contract Systems) – EO/ECH Residuals (2024)

Ventilator HAMILTON-C6 (Hamilton Medical) – Sensor Fail Mode (2024)

Arthroscopy Sup Joint Pack (American Contract Systems) – EO/ECH Residuals (2024)

Artho Knee Beaches Pack (American Contract Systems) – EO/ECH Residuals (2024)

Hand Draping SJH Kit (American Contract Systems) – EO/ECH Residuals (2024)