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 Inc is recalling 36 units of its knee arthroscopy procedure kit due to excessive sterilization chemical residues in the cast padding component that exceed safe exposure limits.
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.
American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.
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 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 is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01AA) due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed acceptable regulatory limits.
American Contract Systems Inc recalls 174 units of CUSTOM KNEE procedure kits due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe exposure limits for permanent contact devices.
American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack procedure tray because sterilant residues (ethylene oxide and ethylene chlorohydrin) exceed safe limits for permanent-use 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 the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.
American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.
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 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.
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.