—#81972

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; REF2D73PB90 - size 9; 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.

FDA product code: KGO — Surgeon'S Gloves
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K042574
Affected lot / code info: lot numbers TS0409472 through TS09020495.

Why it was recalled

Increase in the number of customer complaints due to cuff tears.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.

Timeline

Recall initiated: 2009-04-24
Posted by FDA: 2009-06-18
Terminated: 2010-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.