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U.S. Department of Health and Human Services

Class 1 Device Recall Engage TR Introducer, 6 F ACT (2.25 mm), 12 cm length, .025"

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 Class 1 Recall
Engage TR Introducer, 6 F ACT (2.25 mm), 12 cm length, .025"
see related information
Date Posted August 12, 2010
Recall Status1 Terminated on December 27, 2011
Recall Number Z-2179-2010
Recall Event ID 56222
Premarket Notification
510(K) Numbers
K091137  K092575  K093130 
Product Classification Introducer, Catheter - Product Code DYB
Product St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
Code Information Batch: 3105838
Recalling Firm/
Manufacturer
St. Jude Medical Cardiovascular Division
14901 Deveau Pl
Minnetonka, Minnesota 55345
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.
FDA Determined
Cause 2
DESIGN: Process Design
Action Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.
Quantity in Commerce 90 OUS
Distribution Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
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 = ST. JUDE MEDICAL
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