Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321.

FDA Recall Z-1029-2010 · Posted 2010-03-09

Recalling FirmWescor, Inc
Recall StatusTerminated
Product CodeHYB
Date Initiated2010-01-06
Date Terminated2010-04-20
Product Quantity116 bottles

Reason for Recall

Stains used for diagnostic use may be contaminated with bacteria.

Firm Action

Customers were notified by letter on Jan. 6, 2010 and asked to destroy any remaining product. A response form was included to note whether or not customer had any remaining stock for replacement purposes. Additional information is available at 800-453-2725 or [email protected].

Root Cause

Component design/selection

Distribution Pattern

Nationwide, Foreign distribution to Algeria, Australia, Austria, Canada, Cyprus, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Kuwait, Malta, Netherlands, Oman, Panama, Poland, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, UK, and Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑