Date Initiated by Firm | June 13, 2005 |
Date Posted | August 30, 2005 |
Recall Status1 |
Terminated 3 on January 05, 2007 |
Recall Number | Z-1441-05 |
Recall Event ID |
32395 |
PMA Number | P910073/S3 P910077/S2 P910077S032 |
Product Classification |
Introducer, Catheter - Product Code DYB
|
Product | Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized with gaseous ethylene oxide. |
Code Information |
model 0048, serial numbers 200652 and 200655. model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287. |
Recalling Firm/ Manufacturer |
Guidant Corporation 4100 Hamline Ave N Saint Paul MN 55112-5700
|
For Additional Information Contact | Guidant Technical Services 800-227-3422 |
Manufacturer Reason for Recall | A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use. |
FDA Determined Cause 2 | Other |
Action | By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product. |
Quantity in Commerce | 710 |
Distribution | nationwide and worldwide. |
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.
|