Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404
FDA device recall Z-0909-06 · posted 2006-05-25 · Terminated
Recall details
- Recalling firm
- Gulf South Medical Supply Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYY
- Quantity affected
- 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.
- Date initiated
- 2006-04-10
- Date posted
- 2006-05-25
- Date terminated
- 2007-03-07
- Location
- Jacksonville, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K982872) | Tg Medical Sdn. Bhd. | 1998-10-15 |