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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Vascular COPILOT Kit Bleedback Control Valve

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  Class 2 Device Recall Abbott Vascular COPILOT Kit Bleedback Control Valve see related information
Date Initiated by Firm January 07, 2011
Date Posted July 12, 2011
Recall Status1 Terminated 3 on June 26, 2012
Recall Number Z-2792-2011
Recall Event ID 58979
510(K)Number K991102  
Product Classification Cardiovascular Control Valve - Product Code DTL
Product Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve
Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.
Code Information Lot Number: 0121191
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Keith Krohn
951-914-3324
Manufacturer Reason
for Recall		 Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.
FDA Determined
Cause 2		 Process control
Action Abbott Vascular sent an Urgent Device Recall letter, dated January 7, 2011, noting the products being recalled and the reasons for recall. The firm also provided the following reconciliation instructions to its territory manager: -Help customer identify aflected product. - CaIl Abbott Vascular Customer Service (800) 221-9902 to receive RGA number. Record RGA number below. - Fax this completed form to (951) 914-3826. - Return a copy of this completed form with the returned product
Quantity in Commerce 389 units total
Distribution Nationwide distribution, and Ireland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DTL and Original Applicant = GUIDANT CORP.
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