Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, late
FDA device recall Z-1446-2009 · posted 2009-06-18 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- Increase in the number of customer complaints due to cuff tears.
- Action taken
- 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
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 29,697 cases total
- Distribution
- Worldwide Distribution -- USA, Australia, Austria, Belgium, France, Germany, Japan, New Zealand, Switzerland, Spain, UK, Netherlands, Norway, Sweden, and Turkey.
- Date initiated
- 2009-04-24
- Date posted
- 2009-06-18
- Date terminated
- 2010-05-11
- Location
- Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) (K042574) | Cardinalhealth | 2004-12-08 |