July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls KNEE SCOPE Procedure tray Catalog Number: COKN48L
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
Hazard: 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.
July 17, 2024Medical DevicesFDA
American Contract Systems Inc recalls ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
Hazard: 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.