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

Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.

FDA Recall Z-2335-2008 · Posted 2008-09-20

Recalling FirmIntegra Pain Management
Recall StatusTerminated
Product CodeLZC
Date Initiated2008-07-07
Date Terminated2008-10-29
Product Quantity140 boxes

Reason for Recall

Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.

Firm Action

On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210.

Root Cause

Labeling mix-ups

Distribution Pattern

AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.

Official Source

View FDA Recall →

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

↑