Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0909-06

Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404

Gulf South Medical Supply Inc / initiated 2006-04-10 / Terminated

Gulf South Medical Supply Inc began a recall of Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404 on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0909-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Gulf South Medical Supply Inc
Product
Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404
Product code
LYY Latex Patient Examination Glove
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.
FDA 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 in commerce
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.
Product codes and lots
lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164