Recall Z-2774-2015
Advanced Sterilization Products · initiated August 10, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
Codes / lots: 010713325 010713325 010713324 010713326 010713324 020713327 010713327 010713327 020713327 090713339 020713331 090713339 090713343 090713343 090713345 100713347 110713352 120713353 120713352 100713347 110713352 120713353 150713355 150713356 150713354 160713360 150713356 150713354 150713354 170713361 170713363 170713362 170713363 170713361 170713364 180713368 190713368 190713369 180713368 190713369 290713370 290713370 050813376 050813377 050813377 050813378 070813384 060813379 050813378 070813384 070813383 070813383 070813385 120813391 120813393 070813385 120813392 120813393 140813399 140813400 140813398 140813399 130813398 190813406 190813408 120813391 130813398 120813394 190813406 200813412 210813414 210813415 210813414 210813413 210813415 230813421 230813422 230813422 270813424 270813420 270813423 270813424 290813430 270813420 140813400 190813407 190813408 290813429 290813432 290813429 290813430 290813431 300813435 290813432 290813433 300813435 210813413 290813431 020913434 020913434 020913438 020913438 040913444 040913445 020913438 040913444 030913442 040913443 040913445 060913450 060913450 090913451 090913451 090913452 110913458 110913457 110913459 110913457 160913466…
Reason for recall
Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).
FDA-determined cause: Under Investigation by firm
Action taken
A Urgent Medical Device Field Safety Notice will be sent to customers on 8/10/15 to inform them to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use). The letter provides the customers with the description of the issues and the recommended actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle. For questions regarding the business reply card, customers are instructed to contact Stericycle. Customers with any complaints or suspected problems with CIDEX OPA Solution related to the field safety letter, are instructed to contact 1-888-783-7723.
Details
- Recall number
- Z-2774-2015
- Initiated
- August 10, 2015
- Posted by FDA
- September 16, 2015
- Terminated
- May 20, 2016
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 318,632 cases
- Distribution
- US
- Recalling firm
- Advanced Sterilization Products, Irvine, CA