Recall Z-0909-06 ยท LYY Latex Patient Examination Glove
Gulf South Medical Supply Inc
Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404
| Date | May 25, 2006 (initiated Apr 10, 2006) |
| Status | Terminated |
| Reason | FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin. |
| Root cause | Other |
| Action | The recall is being conducted to the user level. All consignees will be notified by US postal Service letter dated April 10, 2006, first class mail, followed by a phone call. They will be instructed to check their inventory for the lot number of the recalled gloves. Customers who have the product on hand should call the firm at 904-332-4141 to make arrangement for pick up and replacement of the product. |
| Quantity | 815 cases, 100ea per box, 10 bx per case. |
| Distribution | Distributed throughout the following states: PA, VA, MD, NJ, DE, NY, NH, WV, AZ and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) Tg Medical Sdn. Bhd., Oct 15, 1998 |