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

Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

FDA Recall Z-0758-2017 · Posted 2016-12-14

Recalling FirmHalyard Health
Recall StatusTerminated
Product CodeLZA
Date Initiated2016-11-10
Date Terminated2017-05-04
Product Quantity59 cases

Reason for Recall

Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

Firm Action

Consignees were notified by letter via Fed Ex on/about 11/10/2016.

Root Cause

Under Investigation by firm

Distribution Pattern

CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081027KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)Kimberly-Clark Corp. · 2008-06-30

Official Source

View FDA Recall →

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

↑