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

FDA device recall Z-2793-2011 · posted 2011-07-12 · Terminated

Recall details

Recalling firm

Abbott Vascular

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.

Action taken

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

Status

Terminated

Product code

DQY

Quantity affected

389 units total

Distribution

Nationwide distribution, and Ireland.

Date initiated

2011-01-07

Date posted

2011-07-12

Date terminated

2012-06-26

Location

Temecula, CA

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