FDA Device recall Z-2774-2015
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices by Advanced Sterilization Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2774-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-10 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | n/a |
Product
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
Reason
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).
Identifiers
| code_info | 010713325 010713325 010713324 010713326 010713324 020713327 010713327 010713327 020713327 090713339 020713331…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2774-2015%22
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