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; REF2D73PB80 - size 8; Catalog #SOP69CAFCD and #SOP69CAFCE; Cardinal Health, McGaw Park, IL 60085 USA, Made in Thailand. One pair of size 8 gloves was included as a component of the following Presource Custom Sterile Surgery Packs: Catalog #SOP69CAFCD - Clovis Dr Simonian Arthroscopy Pack; Catalog #SOP69CAFCE - Clovis Dr Simonian Arthroscopy Pack. The affected glove pouch was located outside of the sterile pack. 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.
FDA Recall Z-1450-2009 · Posted 2009-06-18
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Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeKGO
Date Initiated2009-04-24
Date Terminated2010-05-11
Product Quantity29,697 cases total
Reason for Recall
Increase in the number of customer complaints due to cuff tears.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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