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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, PowderFree, Medium Size,

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  Class 2 Device Recall Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, PowderFree, Medium Size, see related information
Date Initiated by Firm February 03, 2011
Date Posted March 04, 2011
Recall Status1 Terminated 3 on March 19, 2012
Recall Number Z-1553-2011
Recall Event ID 57988
510(K)Number K081655  
Product Classification Vinyl patient examination glove - Product Code OIG
Product Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Medium Size, Catalog Number: MSV402P, Lot Number: JCU04958569
Code Information Lot Number: JCU04958569
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060
For Additional Information Contact
847-949-3051
Manufacturer 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 Determined
Cause 2		 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 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.
Quantity in Commerce 2,100 cases (2,100,000 units)
Distribution Nationwide Distribution including CA, HI, and NV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OIG and Original Applicant = JIANGSU CUREGUARD GLOVE CO., LTD.
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