Recall Z-2335-2008 ยท LZC Medical Glove, Specialty
Integra Pain Management
Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.
| Date | Sep 20, 2008 (initiated Jul 7, 2008) |
| Status | Terminated |
| Reason | Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex. |
| Root cause | Labeling mix-ups |
| Action | On 07/03/2008, all consignees were notified by telephone and letter titled URGENT MEDICAL DEVICE RECALL. They were instructed to immediately cease distribution/use of any affected product and arrange for its return. Contact number for Integra is 800-241-2210. |
| Quantity | 140 boxes |
| Distribution | AL, CA, FL, LA, NY, SC, TX. No military, government or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.