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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), 25 cm length, .035"

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 Class 1 Device Recall Engage TR Introducer, 6 F ACT (2.25 mm), 25 cm length, .035"see related information
Date Initiated by FirmJune 28, 2010
Date PostedAugust 12, 2010
Recall Status1 Terminated 3 on December 27, 2011
Recall NumberZ-2180-2010
Recall Event ID 56222
510(K)NumberK091137 K092575 K093130 
Product Classification Introducer, Catheter - Product Code DYB
ProductSt. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
Code Information Batch in US and OUS: 3107645 
Recalling Firm/
Manufacturer		 St. Jude Medical Cardiovascular Division
14901 Deveau Pl
Minnetonka MN 55345
For Additional Information Contact
952-933-4700
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		Process design
ActionConsignees 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 Commerce5 US, 10 OUS
DistributionWorldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
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 = DYB
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