Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1553-2011

Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2011-02-03 / Terminated

Medline Industries Inc began a recall of Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569 on . The reason FDA records is "The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1553-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
Product code
OIG Powder-Free Guayle Rubber Examination Glove
Reason for recall
The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.
FDA root cause
Release of Material/Component prior to receiving test results
Action
MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to: 1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock. 3. Fax or email the completed form to Medline. The email address is [email protected] or faxed the form to 866-767-1290. Customers with questions regarding the recall were instructed to contact Medline at 1-866-359-1704 or via e-mail at [email protected].
Quantity in commerce
2,100 cases (2,100,000 units)
Distribution
Nationwide Distribution including CA, HI, and NV.
Product codes and lots
Lot Number: JCU04958569