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U.S. Department of Health and Human Services

Class 2 Device Recall Radiation Reduction Gloves

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 Class 2 Recall
Radiation Reduction Gloves
see related information
Date Posted September 20, 2008
Recall Status1 Terminated on October 29, 2008
Recall Number Z-2335-2008
Recall Event ID 48971
Premarket Notification
510(K) Number
K982832 
Product Classification Patient Examination Glove, 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, Utah 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZC and Original Applicant = EMERSON & CO. S.R.L.
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