Recall Z-1445-2009 ยท KGO Surgeon'S Gloves
Cardinal Health
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; REF2D73PB55 - size 5-1/2; 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
| Date | Jun 18, 2009 (initiated Apr 24, 2009) |
| Status | Terminated |
| Reason | Increase in the number of customer complaints due to cuff tears. |
| Root cause | 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 |
| Quantity | 29,697 cases total |
| Distribution | Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042574 | ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) Cardinalhealth, Dec 8, 2004 |