FDA recall D-0216-2017

Sperian Eye & Face Protection, Inc · Class I · drug

Product

Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818

Reason for recall

Non Sterility; contaminated with Klebsiella pneumoniae

Distribution

Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.

Key facts

Status
Terminated
Initiation date
2016-08-16
Report date
2016-12-28
Termination date
2019-05-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Platteville, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0216-2017