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U.S. Department of Health and Human Services

Class 2 Device Recall Mullins Transseptal Catheter Introducer Sheath

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 Class 2 Recall
Mullins Transseptal Catheter Introducer Sheath
see related information
Date Posted August 05, 2013
Recall Status1 Terminated on March 06, 2014
Recall Number Z-1876-2013
Recall Event ID 65757
Premarket Notification
510(K) Number
K791963 
Product Classification Introducer, Catheter - Product Code DYB
Product Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Code Information Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul, Minnesota 55112-4391
Manufacturer Reason
for Recall
Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control
Action Consignees were sent on 7/8/2013 a Medtronic, Inc " Urgent Medical Device Recall" letter dated 8 July 2013. The letter was addressed to Healthcare Professionals. The letter identified the problem and the product involved in the recall. Advised consignees to remove and quarantine the product from their inventory and return the product. Requested consignees to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. If the product has been further distributed advised consignees to please notify them of the recall.
Quantity in Commerce 269
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = C.R. BARD, INC.
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