Class 2 Device Recall Radiation Reduction Gloves

• Date Initiated by Firm: July 07, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-2335-2008
• Recall Event ID: 48971
• Product Classification: Glove, patient examination, specialty - Product Code LZC
• Product: 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.
• Code Information: Lot No: W0806178, W0806179, and W0806177
• Recalling Firm/ Manufacturer: Integra Pain Management; 3395 W 1820 S; Salt Lake City UT 84104-4921
• For Additional Information Contact: Nola Benstog; 801-886-9505
• Manufacturer Reason for Recall: Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
• FDA Determined Cause: Labeling mix-ups
• 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.
• Quantity in Commerce: 140 boxes
• Distribution: AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.