Device product
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
Z-1182-2018
Product summary
- Event
- Event 79402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 285 cases
- Official record key
device-enforcement:Z-1182-2018
Official wording
Reason: Affected lots may have exceeded its microbial limits.
Code information: EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
Distribution pattern: US Distribution. .
Derived failure modes
-
Unknown
Affected lots may have exceeded its microbial limits.