| |
Class 3 Device Recall |
 |
| Date Initiated by Firm |
September 20, 2005 |
| Date Posted |
November 03, 2005 |
| Recall Status1 |
Terminated 3 on July 22, 2006 |
| Recall Number |
Z-0125-06 |
| Recall Event ID |
33702 |
| 510(K)Number |
K884494
|
| Product Classification |
Introducer, Catheter - Product Code DYB
|
| Product |
Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA |
| Code Information |
Lot 1164732 |
Recalling Firm/
Manufacturer |
St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
|
Manufacturer Reason
for Recall |
A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
|
FDA Determined
Cause 2 |
Other |
| Action |
A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued. |
| Quantity in Commerce |
2000 |
| Distribution |
CA, FL, KY, IL, MN, NY, OH, TN, VA & WI |
| Total Product Life Cycle |
TPLC Device Report
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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 = DYB and Original Applicant = DAIG CORP.
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