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Class 2 Device Recall Mullins Transseptal Catheter Introducer Sheath |
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Date Initiated by Firm |
July 08, 2013 |
Date Posted |
August 05, 2013 |
Recall Status1 |
Terminated 3 on March 06, 2014 |
Recall Number |
Z-1876-2013 |
Recall Event ID |
65757 |
510(K)Number |
K791963
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Product Classification |
Introducer, catheter - Product Code DYB
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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 MN 55112-4391
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For Additional Information Contact |
763-526-6000
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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
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = C.R. BARD, INC.
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