Terminated

Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.

FDA Recall Z-2793-2011 · Posted 2011-07-12

Recalling FirmAbbott Vascular

Recall StatusTerminated

Product CodeDQY

Date Initiated2011-01-07

Date Terminated2012-06-26

Product Quantity389 units total

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.

Firm 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

Root Cause

Process control

Distribution Pattern

Nationwide distribution, and Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031903RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568Guidant Corporation · 2004-03-03 K031459RAPIDO CUT-AWAY CUTTERGuidant Corp. · 2003-07-23 K031688RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVEGuidant Corporation · 2003-07-02 K031505RAPIDO CUT-AWAY GUIDING CATHETERGuidant Corporation · 2003-06-25 K021455RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,Guidant Corp. · 2002-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.