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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Medical

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  Class 2 Device Recall Merit Medical see related information
Date Initiated by Firm May 19, 2009
Date Posted November 23, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall Number Z-0413-2010
Recall Event ID 53619
510(K)Number K984558  
Product Classification Convenience Kits containing recalled surgical gloves - Product Code KDD
Product Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical¿ labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.
Code Information Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
12701 N. Kingston Avenue
Chester VA 23836-2700
For Additional Information Contact Joyce Braxton
804-416-1048
Manufacturer Reason
for Recall		 Surgical gloves in hospital convenience kits may be degraded and tear during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Merit Medical Systems notified customers by phone, fax, or visit by sales representatives on 05/19/09. The notification advised of the convenience kit correction due to the recall of the Derma Prene Ultra Surgical Gloves, and that use of the product should cease immediately. Sales representatives were instructed to provide replacement gloves and "warning" stickers to be placed on identified kits in inventory. The warning stickers advise the customer to discard the surgical gloves in the kit and replace. Customers were requested to verify product disposition by signing a response form.
Quantity in Commerce 378 units
Distribution USA distribution: nine hospitals in Texas and Colorado.
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 = KDD and Original Applicant = ANSELL PERRY
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