Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot

FDA device recall Z-1553-2011 · posted 2011-03-04 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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.

Action taken

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 Recalls@Medline.com 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 Recalls@Medline.com.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

OIG

Quantity affected

2,100 cases (2,100,000 units)

Distribution

Nationwide Distribution including CA, HI, and NV.

Date initiated

2011-02-03

Date posted

2011-03-04

Date terminated

2012-03-19

Location

Mundelein, IL

Related 510(k) clearances