Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Guidant RAPIDO CutAway Guiding Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Guidant RAPIDO CutAway Guiding Cathetersee related information
Date Initiated by FirmJanuary 07, 2011
Date PostedJuly 12, 2011
Recall Status1 Terminated 3 on June 26, 2012
Recall NumberZ-2793-2011
Recall Event ID 58979
510(K)NumberK021455 K031459 K031505 K031688 K031903 
Product Classification Cardiovascular Guiding Catheter - Product Code DQY
ProductGuidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.
Code Information Lot Number: 0120891 and 0121091
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information ContactKeith 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
ActionAbbott 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 Commerce389 units total
DistributionNationwide distribution, and Ireland.
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 = DQY
510(K)s with Product Code = DQY
-
-