FDA recall Z-1182-2018

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.".

Reason for recall

Affected lots may have exceeded its microbial limits.

Distribution

US Distribution. .

Key facts

Status

Terminated

Initiation date

2017-11-03

Report date

2018-04-04

Termination date

2018-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Branford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2018