Z-1445-2009

Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical...

Name: Z-1445-2009 Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical...
Creator: Cardinal Health
Published: 2009-04-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-04-24 / Terminated / root cause: design

FDA source

Cardinal Health began a recall of Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when... on 2009-04-24. The reason FDA records is "Increase in the number of customer complaints due to cuff tears". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1445-2009
Status: Terminated
Initiated: 2009-04-24
Posted: 2009-06-18
Terminated: 2010-05-11
Recalling firm: Medtronic, Inc.
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; 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 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.
Product code: KGO Surgeon'S Gloves
Reason for recall: Increase in the number of customer complaints due to cuff tears.
Root cause tag: design
FDA 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 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.
Product codes and lots: lot numbers TS0409472 through TS09020495.

Product code KGO

K042574Class IEsteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol)Cardinalhealth / cleared 2004-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)