—#97920

Product

Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569

FDA product code: OIG — Powder-Free Guayle Rubber Examination Glove
Device class: Class 1
Medical specialty: General Hospital
510(k) numbers: K081655
Affected lot / code info: Lot Number: JCU04958569

Why it was recalled

The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.

Root cause (FDA determination)

Release of Material/Component prior to receiving test results

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060

Distribution

Distribution pattern: Nationwide Distribution including CA, HI, and NV.

Timeline

Recall initiated: 2011-02-03
Posted by FDA: 2011-03-04
Terminated: 2012-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.