FDA (Devices) recall action 94765
The FDA (Devices) publishes a recall like this one as 39 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 39 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
American Contract Systems is recalling 345 units of the AHAR50K Standard Arthroscopy Pack due to ethylene oxide residue levels exceeding regulatory limits. Affected lot numbers are 638231, 962241, and 898241.
American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.
American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.
American Contract Systems Inc is recalling its KNEE ARTHROSCOPY-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent medical devices. The recall affects 28 units with lot numbers 975241 and 920241.
American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.
American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.
American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.
American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.
American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.
American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.
American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.
American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.
American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.