KKKClass I
Sudan Iv
Hematology · 21 CFR 864.1850
MDR events1All time
Recalls2All time
Registered firms4Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Other1
Most-reported manufacturers
Recalls
2 recall events for this product code
- Customed, IncTerminatedAug 29, 2014
CYSTOSCOPY PACK Ill (1) (2)
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-2465-2014 · View FDA record ↗ - Cardinal Health 200, LLCTerminatedUnknown
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
Z-3046-2017 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code