FDA Recall D-0216-2017
Sperian Eye & Face Protection, Inc · Platteville, WI
Class I — life-threatening Terminated 1017 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0216-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
- Recall initiated
- 2016-08-16
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2019-05-30
- Recalling firm
- Sperian Eye & Face Protection, Inc
- Firm location
- Platteville, WI