Date Initiated by Firm |
March 28, 2007 |
Date Posted |
May 31, 2007 |
Recall Status1 |
Terminated 3 on August 30, 2007 |
Recall Number |
Z-0835-2007 |
Recall Event ID |
37701 |
510(K)Number |
K061772
|
Product Classification |
Embolic Protection System - Product Code FRO
|
Product |
ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. |
Code Information |
Catalog number 61030-01, Lot number 56662 exp 2/28/08 |
Recalling Firm/ Manufacturer |
Kensey Nash Corp 735 Pennsylvania Dr Exton PA 19341-1130
|
For Additional Information Contact |
Robin M. Fatzinger 484-713-2100
|
Manufacturer Reason for Recall |
Insufficient wire sealing
|
FDA Determined Cause 2 |
Other |
Action |
On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted. |
Quantity in Commerce |
11 units |
Distribution |
Worldwide, including USA and Germany. |
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 = FRO and Original Applicant = KENSEY NASH CORP.
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