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U.S. Department of Health and Human Services

Class 2 Device Recall Esteem Blue with Neu Thera Surgeons Glove, size 81/2

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  Class 2 Device Recall Esteem Blue with Neu Thera Surgeons Glove, size 81/2 see related information
Date Initiated by Firm April 24, 2009
Date Posted June 18, 2009
Recall Status1 Terminated 3 on May 11, 2010
Recall Number Z-1451-2009
Recall Event ID 52027
510(K)Number K042574  
Product Classification Surgeon's Gloves - Product Code KGO
Product Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB85 - size 8-1/2; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand.

To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound.
Code Information lot numbers TS0409472 through TS09020495.
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer Reason
for Recall		 Increase in the number of customer complaints due to cuff tears.
FDA Determined
Cause 2		 Device Design
Action Urgent: Product Recall letters dated 4/24/09 were sent to the direct accounts on 4/24/09 via UPS 2-day mail, to the attention of the Director of Materials Management. The accounts were informed of the increased complaints of cuff tears, and were instructed to stop using them and destroy them. The letter included a list of gloves that could be substituted for the recalled gloves. The accounts were requested to call the appropriate customer service group to arrange for credit for the destroyed product, and to complete and return by fax the enclosed acknowledgement form, indicating the number of gloves destroyed.
Quantity in Commerce 29,697 cases total
Distribution Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.
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.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = Cardinal Health
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