Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
FDA Recall Z-1553-2011 · Posted 2011-03-04
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeOIG
Date Initiated2011-02-03
Date Terminated2012-03-19
Product Quantity2,100 cases (2,100,000 units)
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.
Firm 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].
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Nationwide Distribution including CA, HI, and NV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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