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U.S. Department of Health and Human Services

Class 2 Device Recall Grollman Pigtail Catheter

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 Class 2 Device Recall Grollman Pigtail Cathetersee related information
Date Initiated by FirmNovember 05, 2003
Date PostedNovember 27, 2003
Recall Status1 Terminated 3 on December 01, 2003
Recall NumberZ-0159-04
Recall Event ID 27749
510(K)NumberK943739 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
ProductUHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
Code Information Catalog Number 5614-A0, Lot G260778
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		Angiographic catheter tips may separate during use.
FDA Determined
Cause 2		Other
ActionAll 7 consignees were contacted by their sales representatives on 11/5-7/2003.
Quantity in Commerce32 units
DistributionFL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQO
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